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	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2018, during the removal surgery for the femoral neck system (fns), the surgeon had difficulty in removing the locking screw in question together with the handle large with quick coupling.Originally, the patient underwent a surgery for the medial proximal femoral neck fracture with femoral neck system on an unknown date.The surgeon commented that during the removal, relatively large torque is needed to untighten the locking screw of the fns.The surgeon wants the design of the handle with quick coupling changed to the t type wrench shape.The surgeon could only extract the screw by using the lowman bone holding clamp attached to a driver.Procedure was completed successfully with a five (5) minute surgical delay.There was no adverse consequence to the patient.This report is for one (1) handle/large with quick coupling.This is report 2 of 2 for (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: 8298136
• Report Number: 8030965-2019-60576
• Device Sequence Number: 1953424
• 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): 12/14/2018

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1