MAUDE Adverse Event Report: DePuy Ireland - 9616671 ATTUNE; Attune Instruments : Tibial Trials

Catalog Number	254500526
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction

• Brand Name: ATTUNE
• Common Device Name: Attune Instruments : Tibial Trials
• Manufacturer (Section D): DePuy Ireland - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50566552
• Report Number: 1818910-2026-15041
• Device Sequence Number: 15975511
• Product Code: HWT
• UDI-Device Identifier: 10603295132660
• UDI-Public: 10603295132660
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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: 254500526
• Device Lot Number: MVMBKL160
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/13/2026
• Supplement Date Received by Manufacturer: Not provided; 09/07/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/03/2026; 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female