MAUDE Adverse Event Report: SYNTHES HAGENDORF RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.405
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.(b)(6).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review has been requested.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 follow: it was reported that during the surgery on (b)(6) 2017, while distal locking, faulty locking occurred of insertion handle for proximal femoral nail antirotation (pfna) and aiming arm for pfna blade.The surgery was prolonged due to the issue by 15 minutes.No information about patient outcome was reported.Reported concomitant devices: pfna nail (part # 272.265s, lot # l235179, quantity: 1).This report is for one (1) radiolucent insertion handle this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device returned to manufacturer.A device history record (dhr) review was performed on part: 03.010.405 lot: 3443522: manufacturing location: (b)(4), manufacturing date: 26 may 2010.No non conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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.
Additional Manufacturer Narrative
A product investigation was completed: the articles were manufactured according to the specifications and are fully functional.It is likely that there was a technical complication during insertion.The complaint instruments / pfna-nail were investigated the functional test shown the present articles are working without any problems and are fully functional.Unfortunately, as no detailed clinical information is available, we are not able to determine the cause which has led to these circumstances.It is likely that a mechanical overloading situation must have led to these circumstances.No product fault could be detected.The complaint insertion handle was investigated.The evaluation has shown that the part shows some heavy wear marks / hammer blows at the metal - shaft and passage of carbon fiber.The damages have no effect on the functionality of this instrument.The review revealed that the article was manufactured in may 2010 according to the specifications.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances.No indication for material, manufacturing or design related issue was found.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: RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6412771
• Report Number: 3003875359-2017-10124
• Device Sequence Number: 737631
• Product Code: LXH
• UDI-Device Identifier: 10886982068576
• UDI-Public: (01)10886982068576(10)3443522
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 02/16/2017

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: Physician
• Device Catalogue Number: 03.010.405
• Device Lot Number: 3443522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 04/20/2017; 05/05/2017
• 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: PART # 272.265S, LOT # L235179, QUANTITY: 1