MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SHIM SZ7 7MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number	2545-00-744
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	09/02/2020
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.Examination of the returned device confirms the reported event of device wear.The edges of the shim are heavily worn and chipped with material missing.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.
Event or Problem Description
Worn instruments identified by sterilisation, did not occur during surgery.Instruments tagged as damaged and being returned to wa operations via courier.

• Brand Name: ATTUNE SHIM SZ7 7MM
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10754664
• Report Number: 1818910-2020-23520
• Device Sequence Number: 3318473
• Product Code: HWT
• UDI-Device Identifier: 10603295134169
• UDI-Public: 10603295134169
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

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 Model Number: 2545-00-744
• Device Catalogue Number: 254500744
• Device Lot Number: MVMBJA720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1