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

Catalog Number	254900080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: INSTRUMENT CASES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7685006
• Report Number: 1818910-2018-64372
• Device Sequence Number: 16302197
• Product Code: FSM
• UDI-Device Identifier: 10603295476504
• UDI-Public: 10603295476504
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1