MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.486
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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 that on (b)(6) 2020, during the intraoperative process, a resident physician performed a maneuver to impact the nail.When trying to adapt the impact piece to the insertion arch, it did not engage.It was reviewed and found that in some previous procedure, the impactor thread was fatigued within the insertion arch.Another device was used to perform this maneuver.There is no further information available.Concomitant device reported: unknown nail (part # unknown, lot # unknown, quantity 1).This report is for one (1) radiolucent insertion handle for expert nails/100mm.This is report 1 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.Investigation summary on the pictures there are two instruments in a used condition visible.If it does not engage cannot be confirmed base on the pictures.Without having the material available for investigation no further statement can be given.Product was not returned therefore no further investigation possible.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 history lot part: 03.010.486, lot: l366419, manufacturing site: hägendorf, release to warehouse date: june 7, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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: RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10518271
• Report Number: 8030965-2020-06814
• Device Sequence Number: 14123830
• Product Code: LXH
• UDI-Device Identifier: 07611819498853
• UDI-Public: (01)07611819498853
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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): 08/14/2020

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: 03.010.486
• Device Lot Number: L366419
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/12/2020
• 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: DRIVING CAP F/INSERTION HANDLE; UNK - NAILS