MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - DRILL BITS: TRAUMA; BIT, DRILL

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown drill bit/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the proximal femoral nail anti-rotation (pfna) was implanted, however, upon attempting to utilize the distal locking option through the aiming arm, the drill missed the screw hole, and hit the nail.There was a surgical delay of thirty (30) minutes and the procedure was completed successfully.This report is for one (1) unknown drill bit.This is report 4 of 4 for (b)(4).

Event Description

Updated event description: the surgery was successfully completed using an alternate aiming arm from the second set.

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: UNK - DRILL BITS: TRAUMA
• Type of Device: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10666501
• MDR Text Key: 211032000
• Report Number: 8030965-2020-07849
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 11/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1