URGENT MEDICAL DEVICE FIELD SAFETY NOTICE (Removal)

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Transcription:

December 15, 2017 To: Subject: Reference: Surgeons/ Hospitals URGENT MEDICAL DEVICE FIELD SAFETY NOTICE (Removal) FA 2017-05 (ZFA2017-404) Affected Product: REVITAN MODULAR RASP DISTAL CURVED Item Number Product Name 01.00409.612 MOD RASP DISTAL CURVED 14/140 01.00409.613 MOD RASP DISTAL CURVED 16/140 01.00409.614 MOD RASP DISTAL CURVED 18/140 01.00409.615 MOD RASP DISTAL CURVED 20/140 01.00409.616 MOD RASP DISTAL CURVED 22/140 01.00409.617 REVIT RASP DISTAL CURVE 24/140 01.00409.622 MOD RASP DISTAL CURVED 14/200 01.00409.623 MOD RASP DISTAL CURVED 16/200 01.00409.624 MOD RASP DISTAL CURVED 18/200 01.00409.625 MOD RASP DISTAL CURVED 20/200 01.00409.626 MOD RASP DISTAL CURVED 22/200 01.00409.627 MOD RASP DISTAL CURVED 24/200 01.00409.628 REVIT RASP DISTAL CURVE 26/200 01.00409.629 REVIT RASP DISTAL CURVE 28/200 01.00409.633 MOD RASP DISTAL CURVED 16/260 01.00409.634 MOD RASP DISTAL CURVED 18/260 01.00409.635 MOD RASP DISTAL CURVED 20/260 01.00409.636 MOD RASP DISTAL CURVED 22/260 01.00409.637 MOD RASP DISTAL CURVED 24/260 01.00409.638 REVITAN RASP DSTL CURV 26/260 01.00409.639 REVITAN RASP DSTL CURV 28/260 Table 1: Affected products Picture 1: Revitan Rasp Zimmer GmbH is conducting as a precautionary measure a voluntary medical device phased Field Safety Corrective Action (removal) involving certain Revitan Rasp instruments, which were manufactured by a specific vendor in the time period between 2002 and 2008. (Please see attachment 2 for the list of affected lots). The current issue deals with potential breakage of the instrument intra-operatively after an extensive use over time. There is a potential risk for breakage of the rasps during the surgery as indicated in the chart hereafter. The cause for the reported breakage can be multifactorial. CF04108 Rev.1 Ref. CP04102 Field Action Activities Page 1 of 8

Trending of complaint data showed that the fracture rate for these lots are found to be higher (0.54%) than the fracture rate for the Revitan rasp instruments manufactured by a different vendor (0.038%). Zimmer Biomet would like to emphasize the importance of adhering to the applicable surgical technique, Instruction for Use (IFU) and Orthopaedic Reusable Device Instructions. As per the applicable surgical technique 06.01169.012 - Revitan Curved Revision Hip System, the preparation of the implant bed can be achieved by the use of medullary canal reamers, followed by rasp preparation or exclusively rasp preparation. In both techniques, progressive rasping is recommended, starting with either the smallest rasp size and progressively increasing in size or starting at least two sizes smaller than the medullary canal or prosthesis size as measured during preoperative planning. It should also be ensured that no cement residue or osseous obstacles obstruct the free movement of the rasps. As per the applicable IFU (D011500192 (2015-12_87-6204-050-23)): Do not use cutting/sharp instruments with dull or deformed edges or instruments/provisionals that are deformed, corroded, damaged or worn. They may not perform as intended. Precautions Inspect all instruments/ provisionals carefully prior to use Rasps A rasp must advance each time it is struck with a mallet. There is a higher risk of bone fracture or rasp impaction when it does not advance or if the rasp is dull. As per the applicable Orthopaedic Reusable Devices Instructions for Care, Cleaning, Maintenance and Sterilization (97-5000-170-00 Rev. 6); Inspection, Maintenance, Testing and Lubrication Visually inspect for completeness, damage and/or excessive wear. Note: If damage or wear is noted that may compromise the function of the instrument, contact your Zimmer Representative for a replacement. CF04108 Rev.1 Ref. CP04102 Field Action Activities Page 2 of 8

In case of any breakage intra-operatively, the following risks have been identified and evaluated: Risks Describe immediate health consequences (injuries or illness) that may result from use of or exposure to the product issue. Most Probable Coupling part of the curved rasps breaks, the rasp body remains stuck within the femur as the remaining bolt cannot be connected to a handle anymore. Additional medical surgical intervention outside of planned procedures is necessary. The remaining rasps can be removed from the femur and the surgery can be continued with a bigger size of the rasps. Extended surgery time less than 60min. Worst Case Coupling part of the curved rasps breaks, the rasp body remains stuck within the femur as the remaining bolt cannot be connected to a handle anymore. Additional medical surgical intervention outside of planned procedures is necessary. The remaining rasps cannot be easily removed from the femur and the broken rasps needs to strike out via a distal window in the femur. This could also lead to a breakage of the femur itself. Extended surgery time more than 60min. Describe long range health consequences (injuries or illness) that may result from use of or exposure to the product issue. Most Probable A distal window in the femur was necessary to remove the broken rasp which could lead to pain and resulting in an insufficient connection between the implant and the femur of the patient. Worst Case Insufficient connection between the implant and the femur of the patient due to the additional medical surgical intervention outside of planned procedures during surgery could lead to a revision surgery. Our records indicate you may have received one or more of the affected instruments. Surgeon/ Hospital Responsibilities: 1. Review this notification for awareness of the contents. 2. Assist your Zimmer Biomet sales representative to locate affected instruments. 3. Your Zimmer Biomet sales representative will schedule with you the swapping of the affected instruments from your facility. 4. There are no specific patient monitoring instructions related to this Field Safety Corrective Action beyond your existing follow up schedule.. As a manufacturer of medical devices Zimmer Biomet is not licensed to practice medicine. It is up to healthcare professionals to assess the risk and to decide on any patient monitoring, 5. Complete Attachment 1 Certificate of Acknowledgement. a. Return a digital copy to fieldaction.emea@zimmerbiomet.com. b. Retain a copy of the Certificate of Acknowledgement with your field action records in the event of a compliance audit of your documentation. 6. If after reviewing the notice you have further questions or concerns please contact your Zimmer Biomet representative. CF04108 Rev.1 Ref. CP04102 Field Action Activities Page 3 of 8

Other Information This voluntary medical device Field Safety Notice was reported to all relevant Competent Authorities and the related Notified Body as required under the applicable regulations for Medical Devices as per MEDDEV 2.12-1 in Europe. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing winterthur.per@zimmerbiomet.com or to your local Zimmer Biomet contact. Please be aware that the names of user facilities notified are routinely provided to the Competent Authorities for audit purposes. The undersigned confirms that this notice has been delivered to the appropriate Regulatory Agencies. We would like to thank you for your co-operation in advance and regret any inconveniences caused by this field action. Sincerely, Matthias Bürger Zimmer Biomet Vice President QARA EMEA CF04108 Rev.1 Ref. CP04102 Field Action Activities Page 4 of 8

ATTACHMENT 1 Certificate of Acknowledgement By signing below, I acknowledge that the required actions have been taken in accordance with the Recall Notice. [ ] Hospital Facility [ ] Surgeon (Please check one as applicable) Printed Name: Signature: Title: Telephone: ( ) - Date: / / Facility Name: Facility Address: City: ZIP: Country: Note: This form must be returned to Zimmer Biomet before this action can be considered closed for your account. It is important that you complete this form and email a copy to: fieldaction.emea@zimmerbiometcom. Product Reference Lot Reference Number of products identified Number of products to replace CF04108 Rev.1 Ref. CP04102 Field Action Activities Page 5 of 8

Attachment 2: Scope of affected instruments Item Number Lot Number Item Number Lot Number 01.00409.612 06252212 01.00409.625 05.144479 01.00409.612 05.183284 01.00409.625 04.131144 01.00409.612 05.179192 01.00409.625 04.126290 01.00409.612 05.144479 01.00409.625 04.115639 01.00409.612 04.131144 01.00409.625 04.108358 01.00409.612 04.126290 01.00409.625 03.096551 01.00409.612 04.115639 01.00409.625 03.086042 01.00409.612 04.108358 01.00409.625 03.080100 01.00409.612 03.096551 01.00409.625 02.059994 01.00409.612 03.086042 01.00409.625 02.029994 01.00409.612 03.080100 01.00409.625 02.059989 01.00409.612 02.059994 01.00409.626 05.183284 01.00409.612 02.059989 01.00409.626 05.179192 01.00409.613 05.183284 01.00409.626 05.177483 01.00409.613 05.176050 01.00409.626 05.144479 01.00409.613 05.179192 01.00409.626 04.131144 01.00409.613 05.144479 01.00409.626 04.126290 01.00409.613 04.131144 01.00409.626 04.115639 01.00409.613 04.126290 01.00409.626 04.108358 01.00409.613 04.115639 01.00409.626 03.096551 01.00409.613 04.108358 01.00409.626 03.086042 01.00409.613 03.096551 01.00409.626 03.080100 01.00409.613 03.086042 01.00409.626 02.059994 01.00409.613 03.080100 01.00409.626 02.059989 01.00409.613 02.059994 01.00409.627 05.179192 01.00409.613 02.059989 01.00409.627 05.183284 01.00409.614 06252212 01.00409.627 05.177483 01.00409.614 05.183284 01.00409.627 05.144479 01.00409.614 05.179192 01.00409.627 04.131144 01.00409.614 05.144479 01.00409.627 04.126290 01.00409.614 04.131144 01.00409.627 04.115639 01.00409.614 04.126290 01.00409.627 04.108358 01.00409.614 04.115639 01.00409.627 03.096551 01.00409.614 04.108358 01.00409.627 03.086042 01.00409.614 04.103296 01.00409.627 03.080100 01.00409.614 03.096551 01.00409.627 02.059994 01.00409.614 03.086042 01.00409.627 02.059989 CF04108 Rev.1 Ref. CP04102 Field Action Activities Page 6 of 8

Item Number Lot Number Item Number Lot Number 01.00409.614 03.080100 01.00409.628 04.126290 01.00409.614 02.059994 01.00409.628 04.103296 01.00409.614 02.059989 01.00409.629 04.126290 01.00409.615 06244962 01.00409.629 04.103296 01.00409.615 05.183284 01.00409.633 05.183287 01.00409.615 05.179192 01.00409.633 05.179192 01.00409.615 05.144479 01.00409.633 05.144479 01.00409.615 04.131144 01.00409.633 04.131144 01.00409.615 04.126290 01.00409.633 04.126290 01.00409.615 04.115639 01.00409.633 04.115639 01.00409.615 04.108358 01.00409.633 04.108358 01.00409.615 03.096551 01.00409.633 04.105808 01.00409.615 03.086042 01.00409.633 03.096551 01.00409.615 03.080100 01.00409.633 03.086042 01.00409.615 02.059994 01.00409.633 03.080100 01.00409.615 02.059989 01.00409.633 02.059994 01.00409.616 06250007 01.00409.633 02.059989 01.00409.616 05.183284 01.00409.634 06.255334 01.00409.616 05.179192 01.00409.634 06255334 01.00409.616 05.144479 01.00409.634 05.183287 01.00409.616 04.131144 01.00409.634 05.179192 01.00409.616 04.126290 01.00409.634 05.144479 01.00409.616 04.115639 01.00409.634 04.131144 01.00409.616 04.108358 01.00409.634 04.126290 01.00409.616 03.096551 01.00409.634 04.115639 01.00409.616 03.086042 01.00409.634 04.108358 01.00409.616 03.080100 01.00409.634 03.096551 01.00409.616 02.059994 01.00409.634 03.086042 01.00409.616 02.059989 01.00409.634 03.080100 01.00409.617 07299883 01.00409.634 02.059994 01.00409.617 04.126290 01.00409.634 02.059989 01.00409.617 04.103296 01.00409.635 06.250007 01.00409.622 06226062 01.00409.635 06250007 01.00409.622 05.183284 01.00409.635 05.183287 01.00409.622 05.179192 01.00409.635 05.179192 01.00409.622 05.144479 01.00409.635 05.144479 01.00409.622 04.131144 01.00409.635 04.131144 01.00409.622 04.126290 01.00409.635 04.126290 01.00409.622 04.115639 01.00409.635 04.115639 01.00409.622 04.108358 01.00409.635 04.105808 CF04108 Rev.1 Ref. CP04102 Field Action Activities Page 7 of 8

Item Number Lot Number Item Number Lot Number 01.00409.622 03.096551 01.00409.635 04.108358 01.00409.622 03.086042 01.00409.635 03.096551 01.00409.622 03.080100 01.00409.635 03.086042 01.00409.622 02.059994 01.00409.635 03.080100 01.00409.622 02.059989 01.00409.635 02.059994 01.00409.623 06250007 01.00409.635 02.059989 01.00409.623 05.183284 01.00409.636 06.255334 01.00409.623 05.179192 01.00409.636 06255334 01.00409.623 05.144479 01.00409.636 05.183287 01.00409.623 04.131144 01.00409.636 05.179192 01.00409.623 04.126290 01.00409.636 05.144479 01.00409.623 04.115639 01.00409.636 04.131144 01.00409.623 04.108358 01.00409.636 04.126290 01.00409.623 04.105808 01.00409.636 04.115639 01.00409.623 03.096551 01.00409.636 04.108358 01.00409.623 03.086042 01.00409.636 03.096551 01.00409.623 03.080100 01.00409.636 03.086042 01.00409.623 02.059994 01.00409.636 03.080100 01.00409.623 02.059989 01.00409.636 02.059994 01.00409.624 06.250007 01.00409.636 02.059989 01.00409.624 06250007 01.00409.637 07265997 01.00409.624 05.183284 01.00409.637 05.183287 01.00409.624 05.179192 01.00409.637 05.179192 01.00409.624 05.144479 01.00409.637 05.144479 01.00409.624 04.149104 01.00409.637 04.149104 01.00409.624 04.131144 01.00409.637 04.131144 01.00409.624 04.126290 01.00409.637 04.126290 01.00409.624 04.115639 01.00409.637 04.115639 01.00409.624 04.108358 01.00409.637 04.108358 01.00409.624 04.105808 01.00409.637 03.096551 01.00409.624 03.096551 01.00409.637 03.086042 01.00409.624 03.086042 01.00409.637 03.080100 01.00409.624 03.080100 01.00409.637 02.059994 01.00409.624 02.059994 01.00409.637 02.059989 01.00409.624 02.059989 01.00409.638 04.126290 01.00409.625 06255334 01.00409.638 04.103296 01.00409.625 05.183284 01.00409.639 04.126290 01.00409.625 05.172716 01.00409.639 04.103296 01.00409.625 05.179192 - - CF04108 Rev.1 Ref. CP04102 Field Action Activities Page 8 of 8

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