MAUDE Adverse Event Report: SYNTHES GMBH FIX-SLEEVE F/STEPPED REAMER; MISC ORTHO SURGICAL INSTR

Catalog Number	03.037.023
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent open reduction internal fixation surgery for her femoral trochanteric fracture.During the surgery, the guide wire sleeve broke the exterior cortical bone and contacted with the nail.The surgery was completed successfully with 30 minutes delay.The patient outcome was stable.Concomitant device reported: unknown guidewire (part # unknown, lot # unknown, quantity 1), unknown reamer (part # unknown, lot # unknown, quantity 1), unknown hammer (part # unknown, lot # unknown, quantity 1).This complaint involves eight (8) devices.This report is for (1) fix-sleeve f/stepped reamer.This report is 6 of 8 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6- the parts that have been provided are fully functional.The complaint describes that the guide wire penetrated the humeral head during impaction of the blade.The guidewire is supposed to move independently form the provided parts.The guide wire used for the test did move freely and thus another reason for a jamming an thus displacement during impaction might be the original guide wire which was not provided.The complaint also describes that the sleeve penetrated the lateral cortex and contacted the nail.This is possible if the nut is sliding freely.The clicking and blocking of the nut is done in combination with the aiming arm which was not provided.Tested with the aiming arm at hand the nut functioned as intended.The original aiming arm that might be the reason for a free sliding nut and thus reason for an unintended change of depth was not provided.Furthermore, it was described that the blade was hard to insert and that the sleeve touched the nail.A misalignment between the aiming arm, the aiming arm attachment, the nail, the sleeve and the blade could explain this complaint.Due to the missing original components of that construct, this can not be evaluated.The missing color coding is not responsible for the described complaint.Even with the missing color-coding the instruments can only be assembled in the correct way but it might need some ¿twiddling¿ to assemble it.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot : part: 03.037.023, lot: 9258421, manufacturing site: hägendorf, release to warehouse date: 25 march 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: FIX-SLEEVE F/STEPPED REAMER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10912537
• Report Number: 8030965-2020-09240
• Device Sequence Number: 14174388
• Product Code: LXH
• UDI-Device Identifier: 07611819642492
• UDI-Public: (01)07611819642492
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.037.023
• Device Lot Number: 9258421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 12/17/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BUTTRESS/COMPR-NUT; CONNECSCR F/TFNA HELIC BLADE+SCR; GUIDE SLEEVE YELL; GUIDEWIRE Ø3.2 L400; TFNA HELICAL-BLADE IMPACT; UNK - GUIDEWIRE; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - NAIL HEAD ELEMENTS: HELICAL BLADE; UNK - NAILS: FEMORAL; UNK - REAMERS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR