MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH GUIDE WIRE 3.2MM FOR PFNA BLADE

Catalog Number	356.83
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been 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 synthes reports an event in (b)(6) as follows: it was reported that during the trochanteric fixation nail-advanced (tfna) implantation on (b)(6) 2020, the stepped drill have broken out.The reason was not reported.There were no patient consequences reported.During manufacturer's preliminary investigation of the returned device on (b)(6) 2020 it was identified that an guide wire ø 3.2mm jammed in the core hole of stepped reamer.This report is for one (1) guidewire 3.2mm for pfna blade.This is report 2 of 2 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.Part: 356.830, lot: 39p3398, manufacturing site: balsthal, release to warehouse date: february 24, 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the visual inspection has shown that the guide wire 3.2mm is stuck in the cannulated bore hole of the returned stepped reamer for tfna helic blade.The removed guide wire is in a bad condition.The guide wire has some heavy dents and marks visible as well as stripped threaded tip.Drawing/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.Summary: the complaint is confirmed as the removed guide wire from the cannulated stepped reamer has some heavy dents and marks visible as well as stripped threaded tip.During the evaluation no manufacturing related issue could be identified, the device was manufactured according to the specification.There are clearly visible stress marks of grinding at the whole surface of the guide wire as well as stripped threaded tip.These marks are an indication for an excessive metallic contact of the stepped reamer.We have to assume that there was a technical complication during insertion of the guide wire.The protection sleeve of guide wire was not in contact with the bone, which finally caused the malposition of the wire and finally the post manufacturing damages of the guide wire.The root cause was identified during the performed customer quality (cq) evaluation and therefore the in the investigation flow listed remaining investigation steps "dimensional inspection:" are not required.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.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: GUIDE WIRE 3.2MM FOR PFNA BLADE
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10111385
• Report Number: 8030965-2020-03867
• Device Sequence Number: 19679840
• Product Code: FZX
• UDI-Device Identifier: 07611819291355
• UDI-Public: (01)07611819291355
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 356.83
• Device Lot Number: 39P3398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STEPPED REAM F/TFNA HELIC BLADE+SCR F/DH