MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH GUIDEWIRE Ø3.2 F/PFNA BLADE

Catalog Number	356.830
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that during a proximal femoral nail antirotation (pfna) case on (b)(6) 2018, the pfna blade could not be locked in place.Initially, it was observed that the unknown insertion handle would not lock into the unknown protection sleeve, thus not locking the blade all the way.In the surgeon¿s attempt to reattach the blade and lock it fully, the blade was completely screwed from its housing instead and could not be recovered.Locking the blade was abandoned and the blade was left inside the patient.The surgeon noted that the blade should have a fail safe option so that it cannot disengage and therefore always lock effectively.It was also noted that the guide wire for pfna blade was bent when it was removed.There was a 30-minute surgical delay reported due to the device issue.The procedure was completed but with the blade sitting a little bit out than it would normally be.It is unknown what the patient outcome was.This report is for one (1) guide wire 3.2mm for pfna blade.This is report 2 of 4 for complaint (b)(4).
Additional Manufacturer Narrative
Additional narrative: 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
Further it was reported that the reported incident was not due to instrument but due to either surgical technique or blade itself.

• Brand Name: GUIDEWIRE Ø3.2 F/PFNA BLADE
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7758483
• Report Number: 8030965-2018-55536
• Device Sequence Number: 19271655
• Product Code: FZX
• UDI-Device Identifier: 07611819291355
• UDI-Public: (01)07611819291355
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 356.830
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1