MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SILICONE HANDLE QUICK COUPLING/SHORT; MISC ORTHO SURGICAL INSTR

Catalog Number	03.111.013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown date in 2019.Initial reporter is synthes sales representative.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 an unknown date in 2019 the handle broke into two parts when using with the chisel.Alternate instrument was used after that.No patient status reported.Concomitant device reported: unknown chisel (part# unknown, lot# unknown, quantity 1).This report is for one (1) silicone handle quick coupling/short.This is report 1 of 1 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.A review of the device history record.Device history lot.Part: 03.111.013.Lot: l395008.Manufacturing site: bettlach.Release to warehouse date: 22.Aug.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation selection.Investigation site: cq zuchwil.Selected flow: damage.Visual inspection: the device was received with the handle broken off from the base body with quick coupling.The microscopic observation shows remaining laser weld on the conjunction between both parts.The handle shows heavy hammer blows on the top of the instrument.An foreign red colored adhesive tape was found on the handle.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: a dimensional test is not appropriate, since all complaint-relevant dimensions can no longer correspond to the valid technical drawings specifications due to the damage incurred.Document/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.As indicated in the manufacturing documents, the damaged instrument underwent crack-test and torque testing to 100% before the part left manufacturing site.The damage was clearly caused post manufacturing conclusion: our investigation has shown that the complaint condition is confirmed due to the received condition of the device.The microscopic observation shows remaining laser welds on both involved components showing that the weld joint was correct at the time of manufacturing.The root cause of the breakage can be addressed to excessive force application on the device as hammer blows were found on the top of the instrument.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed 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: SILICONE HANDLE QUICK COUPLING/SHORT
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8887912
• Report Number: 8030965-2019-67150
• Device Sequence Number: 3039284
• Product Code: LXH
• UDI-Device Identifier: 07611819373334
• UDI-Public: (01)07611819373334
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 07/16/2019

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: 03.111.013
• Device Lot Number: L395008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/30/2019
• 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 - CUTTING INSTRUMENTS: CHISEL: TRAUMA