MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE SHIM SZ5 5MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number 254500651

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2019

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 5mm size 5&6 shim was found to be broken during the decontamination process.There was no patient involved in the incident.No surgical delay.

Manufacturer Narrative

(b)(4).Investigation summary
=
> examination of the returned device confirms the reported event.Depuy considers the investigation closed.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 will be filed as appropriate.

• Brand Name: ATTUNE SHIM SZ5 5MM
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• 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: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 8646844
• MDR Text Key: 146263297
• Report Number: 1818910-2019-94614
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295133438
• UDI-Public: 10603295133438
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

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: 254500651
• Device Lot Number: MVMBJC310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 06/10/2019
• Supplement Dates FDA Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/02/2013
• 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