MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DRIVER EXTRACTOR; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Model Number 2046-10-000

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that while using the slap hammer extractor handle, the handles threads became flat and would not screw back into slap hammer attachment.While using the thin osteotome handle holder, the dial to tighten the thin osteotome in place became loose and the threads were broken as well.We believe both these instruments have been used so much that the lifespan of the instruments broke because regular wear and tear over time.These instruments had no negative affect on the outcome of the case and no pieces broke off that could have caused a problem.No surgical delay.

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.Product complaint # : (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRIVER EXTRACTOR
• Type of Device: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9608137
• MDR Text Key: 189238592
• Report Number: 1818910-2020-02333
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295084365
• UDI-Public: 10603295084365
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 2046-10-000
• Device Catalogue Number: 204610000
• Device Lot Number: AY0298F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/20/2020
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR