MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH I RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.405
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report was initially submitted on october 09, 2019 but the fda site was down.Advised by fda on november 01, 2019 to resubmit medwatch.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on an unknown date that an issue occurred during the distal locking in a pfna short 170mm/125°/d 10 mm.The implants ( nail and screws ) are implanted in the patient.Patient condition is unknown.Concomitant devices reported: unknown pfna short nail (part# unknown, lot# unknown, quantity 1); unknown locking screw (part# unknown, lot# unknown, quantity 1).This is report 1 for 8 (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.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot part: 03.010.405, lot: 3425389, manufacturing site: hägendorf, release to warehouse date: may 12, 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance 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: I RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9265563
• Report Number: 8030965-2019-69181
• Device Sequence Number: 11416970
• Product Code: LXH
• UDI-Device Identifier: 07611819349421
• UDI-Public: (01)07611819349421
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/12/2019

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: 3425389
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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: UNK - NAILS: PFNA; UNK - SCREWS: LOCKING