MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE REV STEM TRIALS CASE; INSTRUMENT CASES

Catalog Number 254900080

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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 tray was delaminating and plastic stem holder was broken.This was noticed at territory office, not at the hospital.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary: examination of the returned device confirms the reported event of bracket breakage and fading of the markings on the bottom of the instrument case.Upon further investigation, there was opportunity to strengthen some of the brackets in this case, which was done by creating a solid spine across the base of six rows of brackets.This design change was incorporated via revision e of drawing (b)(4).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 will be filed as appropriate.

• Brand Name: ATTUNE REV STEM TRIALS CASE
• Type of Device: INSTRUMENT CASES
• 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: 7685006
• MDR Text Key: 113877500
• Report Number: 1818910-2018-64372
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10603295476504
• UDI-Public: 10603295476504
• 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: 06/20/2018

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: 254900080
• Device Lot Number: PV0156619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/13/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• 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