MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE EM TIBIAL PROX UPROD; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES

Catalog Number	254400018
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported one instrument in the short-term-loaner-kit (orthokit) showed wear.The last loan system "attunes" delivered comes with an instrument that is defective.The plastic abrasion on the adjustment lever makes it impossible to use it.There was no surgical delay.No patient consequence.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 4/27/2023.3) any anomalies or deviations identified in dhr: none.4) expiry date: n/a.5) ifu reference: 090200836 rev j.Device history review: 1) quantity manufactured: (b)(4).2) date of manufacture: 4/27/2023 3) any anomalies or deviations identified in dhr: none 4) expiry date: n/a 5) ifu reference: 090200836 rev j.

• Brand Name: ATTUNE EM TIBIAL PROX UPROD
• Common Device Name: ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21880932
• Report Number: 1818910-2025-06067
• Device Sequence Number: 18303020
• Product Code: LXH
• UDI-Device Identifier: 10603295434054
• UDI-Public: (01)10603295434054(10)PG335201
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• 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: 254400018
• Device Lot Number: PG335201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2023
• 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