MAUDE Adverse Event Report: DePuy Ireland - 9616671 ATTUNE; Attune Instruments : Spacer Blocks/Trial Shims

Catalog Number	254401014
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction

• Brand Name: ATTUNE
• Common Device Name: Attune Instruments : Spacer Blocks/Trial Shims
• Manufacturer (Section D): DePuy Ireland - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 1302 wrights lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50764057
• Report Number: 1818910-2026-15799
• Device Sequence Number: 9414646
• Product Code: HWT
• UDI-Device Identifier: 10603295395379
• UDI-Public: (01)10603295395379(10)BFA109J
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 254401014
• Device Lot Number: BFA109J
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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 Age: 82 YR
• Patient Sex: Male