MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV SHIM SZ3 16MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number	2545-00-919
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
Broken instruments sustained over the christmas period.Email provides details of what instruments are broken with the relevant batch numbers.The email does not provide information on where or how these instruments broke and if debris was generated.

• Brand Name: ATTUNE CONV SHIM SZ3 16MM
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11166820
• Report Number: 1818910-2021-01044
• Device Sequence Number: 3559288
• Product Code: HWT
• UDI-Device Identifier: 10603295134961
• UDI-Public: 10603295134961
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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: 2545-00-919
• Device Catalogue Number: 254500919
• Device Lot Number: BFA11HF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 01/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1