MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE REVISION BROACH HANDLE; HANDLES

Catalog Number 254600418

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2018

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 tibia sleeve broach was popping off the broach handle while broaching the tibia.The handle seemed to be loose and while using mallet to try to remove broach the handle would open up causing handle release sleeve broach, i asked surgeon to try and use his hand to keep handle closed while using the mallet to extract the sleeve broach and with handle still closed it still popped off the broach handle, ended up threading in a extraction device in the set and came out with little effort.Surgical delay: 15 minutes.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device(s) could not confirm the reported event.Product problem has not been identified.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: ATTUNE REVISION BROACH HANDLE
• Type of Device: HANDLES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7684967
• MDR Text Key: 113875360
• Report Number: 1818910-2018-64362
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295475910
• UDI-Public: 10603295475910
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254600418
• Device Lot Number: AB4187369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/13/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR