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

Catalog Number	03.010.516
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part number: 03.010.516.Lot number: t120595.Manufacturing site: tuttlingen.Release to warehouse date: 18-mar-2016.A review of the device history records was performed for the finished device lot number, and no non-conformance's were identified.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) 2019, the patient got the right femoral neck fracture (garden) by an unknown reason.On the same day, the patient underwent an open reduction internal fixation surgery with a femoral neck system (fns).Patient made good progress after the operation.However, the patient fell on (b)(6) 2020 and got right femoral subtrochanteric fracture and left proximal humeral fracture.On the same day, the patient underwent reoperation and the fns was replaced by trochanteric fixation nail advanced (tfna) with the purpose of fixing the subtrochanteric fracture.There was no disposition in the femoral neck fracture.During the reoperation, the surgeon had difficulty in removing the locking screw with a screwdriver shaft and a handle because the torque was insufficient.He used another screwdriver shaft instead and removed the screw successfully.There was no surgical delay.No further information is available.This report captures the intraoperative difficulty in removal of implants using a screwdriver shaft and a handle, while related complaint (b)(4) captures the revision surgery performed on (b)(6) 2020 due to second fracture.Concomitant device reported: locking screw (part# 412.212s, lot# l755620, quantity 1).This report is for one (1) handle/large with quick coupling.This is report 2 of 2 for complaint (b)(4).

• Brand Name: HANDLE/ LARGE WITH QUICK COUPLING
• Common Device Name: TAP,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9627166
• Report Number: 8030965-2020-00599
• Device Sequence Number: 354309
• Product Code: HWX
• UDI-Device Identifier: 07611819499126
• UDI-Public: (01)07611819499126
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2020

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: 03.010.516
• Device Lot Number: T120595
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 34