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

Catalog Number 254600418

Device Problem Connection Problem (2900)

Patient Problem No Code Available (3191)

Event Date 06/25/2018

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 attune revision broach handles will not hold on to the tibial or femoral broach when back-slapping against the handle! we tried both handles on both bones.Broach and handle tip were pristenely clean.We were able to replicate on the back table multiple times.Either the locking arm on the handle is too short or the locking mechanism within the handle is too weak.This delay caused over 10 minutes of delay in the operating room.The surgeon is expecting a written response and phone correspondence with the knee marketing or knee engineering team.There was absolutely deficiency in this instrument today.Surgical delay: 10 minutes.

Manufacturer Narrative

Investigation summary: no device associated with this report was received for examination.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.Device history lot: null.Device history batch: null.Device history review: null.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: 7697846
• MDR Text Key: 114294713
• Report Number: 1818910-2018-64641
• 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: 06/25/2018

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 Catalogue Number: 254600418
• Device Lot Number: AB4187369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 09/27/2018
• Supplement Dates FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 59 YR