MAUDE Adverse Event Report: DePuy Ireland - 3015516266 ATTUNE; Attune Instruments : Instrument Cases

Catalog Number	254501709
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Macro 9/10 tray that was sent for replacement of the other one that had broken plastic, also had broken plastic liner.Product was not put into circulation.No patient contact.Found prior to circulation and sterilization.Broken plastic in cut block size 10 base of tray.Was there any reported patient or user harm? no.Was there a significant delay? no.Additional information: broken plastic in cut block size 10 section base of the tray.It has a cracked section that is missing plastic when it arrived from set creations as a replacement product.Product was not put into circulation, and was immediately put aside for return.No patient contact.Found prior to circulation and sterilization.Reporter stated that they were not aware of any plastic pieces leaving the case or being found in the case when it arrived at the hospital from set creation.The case was not accepted by the hospital.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE
• Common Device Name: Attune Instruments : Instrument Cases
• Manufacturer (Section D): DePuy Ireland - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50475535
• Report Number: 1818910-2026-14680
• Device Sequence Number: 10323512
• Product Code: FSM
• UDI-Device Identifier: 10603295423591
• UDI-Public: (01)10603295423591(10)PV0098154
• Combination Product (Y/N): N
• 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: Foreign,Company Representative
• Type of Report: Initial,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: 254501709
• Device Lot Number: PV0098154
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/28/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/06/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2021
• 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: Unknown