MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE INST SZ 9-10; ATTUNE INSTRUMENTS : INSTRUMENT CASES

Catalog Number	254501709
Medical Device Problem Codes	Material Discolored (1170); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
During initial tray assessment and inspection prior to medical device reprocessing, medical device reprocessing staff noticed that several instrument trays within the attune knee system family of instrument trays contained grey coloured inner tray liners which contain enough space on each end between the main outer shell and the grey inner tray liner for debris or material to get down in between, with the potential for said debris or material to remain down in between the grey inner liner and the outer tray shell and not be able to be washed and properly cleaned.Although it was subsequently determined that the grey inner liner of these complained trays can in fact be removed, thus facilitating proper cleaning, the removal of the inner grey liner is only possible with the use of an external tool.Upon inspection, beneath the grey tray liners once removed, an article (a biological indicator from another facility), was discovered.There was no patient consequence.

• Brand Name: ATTUNE INST SZ 9-10
• 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 ; 9083863534
• MDR Report Key: 23384033
• Report Number: 1818910-2025-18267
• Device Sequence Number: 9046296
• Product Code: FSM
• UDI-Device Identifier: 10603295423591
• UDI-Public: (01)10603295423591
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 254501709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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