MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SHIM SZ9 7MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number	2545-00-745
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
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.
Event or Problem Description
It was reported that shims found broken in sterile processing.No surgical delay.

• Brand Name: ATTUNE SHIM SZ9 7MM
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11008981
• Report Number: 1818910-2020-26940
• Device Sequence Number: 19020865
• Product Code: HWT
• UDI-Device Identifier: 10603295134176
• UDI-Public: 10603295134176
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 2545-00-745
• Device Catalogue Number: 254500745
• Device Lot Number: BFA0MR4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1