MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PRIMARY RESECTIONS; ATTUNE INSTRUMENTS : INSTRUMENT CASES

Model Number	2545-01-701
Medical Device Problem Codes	Material Twisted/Bent (2981); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
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.Investigation summary: examination of the returned instrument tray revealed several of the plastic brackets were chipped and broken.The investigation did not establish that a broader investigation or corrective action was necessary.Depuy-synthes 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
34 hospital consigned instrument trays that over 9 years old are worn and beyond use.No patient consequences or surgical delays reported.

• Brand Name: ATTUNE PRIMARY RESECTIONS
• Common Device Name: ATTUNE INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11912303
• Report Number: 1818910-2021-11402
• Device Sequence Number: 11116173
• Product Code: FSM
• UDI-Device Identifier: 10603295423515
• UDI-Public: 10603295423515
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/08/2021

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: 2545-01-701
• Device Catalogue Number: 254501701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1