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	12/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Manufacturing location: (b)(4).Manufacturing date: november 09, 2010.No non-conformance reports 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 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 (b)(4) reports an event in (b)(6) as follows: it was reported that during surgery on (b)(6), a distal locking of a proximal femoral nail anti-rotation (pfna) system was not able to be used as planned.The locking bolt did not fit with the hole of the nail properly.An insertion handle for pfna, aiming arm, drill sleeve and a protection sleeve were involved as well.Locking of the pfna nail and locking bolt was achieved manually; as such it was deduced that insertion handle for pfna, aiming arm, drill sleeve and a protection sleeve were misaligned.The surgery was prolonged by thirty (30) minutes, but without patient harm.Reported concomitant parts: pfna nail (part: unknown, lot: unknown, quantity: 1); locking bolt (part: unknown, lot: unknown, quantity: 1).This is report 1 of 2 for com-(b)(4).
Additional Manufacturer Narrative
Device returned to manufacturer.A product investigation was performed.The complaint instruments were investigated together with the responsible trauma - sustaining manager.A functional test shown the present articles is 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.Since we are not aware of exactly circumstances during the surgery we suppose 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 november 2010 according to the specifications.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformance.The evaluation of these instruments (part #: 356.828 / lot #: 7772289 drillsl 8/4 green, part #: 356.831 / lot #: 7779274 protect sleeve 11/8 green) has shown that the parts shows in good condition, no other damaged or deviation are visible.The articles were manufactured according to the specifications and are fully functional.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformance.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: 6245532
• Report Number: 3003875359-2017-10019
• Device Sequence Number: 907051
• Product Code: LXH
• UDI-Device Identifier: 10886982068576
• UDI-Public: (01)10886982068576(10)3586876
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2016

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: 03.010.405
• Device Lot Number: 3586876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 02/06/2017
• 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: 1 UNKNOWN LOCKING BOLT; 1 UNKNOWN PFNA NAIL