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

Model Number 2046-10-000

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Code Available (3191)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

(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 the surgeon was attempting to broach the femoral canal of patient indicated above.The broach got stuck in the canal, so they had to open the stem removal tray, which included a depuy slap hammer.With the use of a depuy adapter, the slap hammer was attached to the stem distractor and an attempt was made to remove the broach from the patient's canal.Unfortunately, in the process, the slap hammer and adapter was damaged beyond repair.To review.One slap hammer was damaged as well as one adapter, the case was delayed , but the surgeon understood , considering the circumstances.All broken pieces were retrieved and he apologized for the damage.There was 90 minutes surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• 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: 10554506
• MDR Text Key: 207563154
• Report Number: 1818910-2020-20480
• 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: 09/08/2020

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: A1109
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR