MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BAR FOR SMALL F-TOOL; MISC ORTHO SURGICAL INSTR

Catalog Number	359.207
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is company representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 during an unknown surgery on an unknown date, the threads of a bar for f-tool and threaded rod for f-tool broke.The surgery was successfully completed with no surgical delay.Patient outcome is unknown.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.Part: 359.207.Lot: 2085882.Manufacturing site: bettlach.Release to warehouse date: april 13, 2004.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the device 359.208 was found broken at it's threaded tip.The broken tip is stuck into the threaded hole of the article 359.207.Both devices are in very used condition.No other issues were identified with the returned components of the device.Dimensional inspection: dimensional analysis could not be performed as relevant features are deformed through post manufacturing damage.Conclusion: our investigation has shown that the complaint condition is confirmed due to the received condition of both devices.Due to the heavy wear and tear signs, we can assume that this products were often and intensive used.We do suppose that the device encountered unintended forces, such as being dropped on the floor and/ or excessive force application during its use, which finally resulted in the breakage of the pin.By the evidence that this device was used successfully over its 15 (fifteen) years of lifespan and the damages are clearly caused post manufacturing, we can conclude that the cause of failure is not due to any manufacturing non-conformances.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.
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.B4/g4 in original report was june 27, 2019.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: BAR FOR SMALL F-TOOL
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8815867
• Report Number: 8030965-2019-66492
• Device Sequence Number: 3258480
• Product Code: LXH
• UDI-Device Identifier: 07611819710580
• UDI-Public: (01)07611819710580
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/27/2019

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: 359.207
• Device Lot Number: 2085882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 07/23/2019; 08/13/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 07/23/2019; 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1