MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LARGE HANDLE WITH QUICK COUPLING; TAP,BONE

Catalog Number 311.431

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent removal surgery of a distal fibula plate for an unknown reason with the handle with quick coupling in question.During the removal surgery, the surgeon couldn¿t connect a screwdriver shaft to the handle.The surgeon used another screwdriver, and the surgery was completed successfully with less than 30minutes delay.After the surgery, when the hospital checked the handle, the screwdriver shaft couldn¿t be connected to the handle.This report is for one large handle with quick coupling.This is report 1 of 2 for (b)(4).

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.H3, h6: 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.

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 site: cq zuchwil , selected flow: device interaction / functional.Visual investigation: the returned handle with quick coupling is in very used condition and shows wear marks and scratches on the surface of the whole instrument.The coupling is stiff and therefore not easy to use.The coupling is still able to hold the instrument in place but based on the fact that the instrument is very old and in used condition a proper handling is not given anymore.Conclusion: after a visual inspection per guidance provided in windchill document # 0000277191, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Part: 311.431, lot: 7936985, manufacturing site: bettlach, release to warehouse date: jun.12, 2012.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: LARGE HANDLE WITH QUICK COUPLING
• Type of Device: TAP,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9583268
• MDR Text Key: 190750894
• Report Number: 8030965-2020-00328
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 07611819259836
• UDI-Public: (01)07611819259836
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.431
• Device Lot Number: 7936985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Date Manufacturer Received: 02/12/2021
• Patient Sequence Number: 1