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	03/25/2019
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 japan reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent a revision bipolar hip arthroplasty procedure.Initially, the patient had an osteosynthesis for a femoral neck fracture with femoral neck system (fns) on (b)(6) 2018.However, on (b)(6) 2019, the patient reported pain.Thus, a re-operation was performed.During re-operation, the surgeon started by extracting the locking screw in question using a screwdriver stardrive, but the screw could not be untightened.So, the surgeon checked that there was no bone fragment in the screw head and connected the screwdriver with the screw firmly by hammering lightly.Unfortunately, the surgeon could not rotate the screw at all.Thus, the surgeon tried using the stardrive screwdriver, but the problem did not improve.Then, the surgeon used a screwdriver shaft stardrive and large handle with quick coupling which wrapped with an esmarch to apply a stronger force to untighten the screw but was still unsuccessful.Finally, the surgeon connected the screwdriver stardrive with a non-synthes rasp handle making t handle-like device and rotated the screw and the screw was removed successfully.The surgery was delayed by less than thirty (30) minutes.Patient status and procedure outcome are unknown.Concomitant devices: fns plate (part: 04.168.000s, lot: l769337, quantity: 1), fns bolt (part: 04.168.285s, lot: l828733, quantity: 1), antirotation screw (part: 04.168.485s, lot: l632897, quantity: 1).This report is for a handle/ large with quick coupling.This is report 5 of 5 for (b)(4).
Event or Problem Description
Unknown hammer (part# unknown, lot# unknown, quantity 1).
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.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: 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: 8527332
• Report Number: 8030965-2019-62918
• Device Sequence Number: 1885189
• 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,Followup
• Report Date (Section B): 03/25/2019

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: 03.010.516
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/20/2019
• 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: ANTIROTATION SCREW; BOLT; FNS PLATE; UNK HAMMER