MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE EM TIBIAL DIST UPROD; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES

Catalog Number	254400003
Medical Device Problem Codes	Device-Device Incompatibility (2919); Mechanical Jam (2983); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
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.
Event or Problem Description
The up rod would not slide onto the ankle clamp correctly.It scratched the metal and felt very tight, getting stuck at the very distal end of the ankle clamp.Scratches appeared on the inner metal work of the up rod.There was a five minute surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary according to the information received, ¿the up rod would not slide onto the ankle clamp correctly.It scratched the metal and felt very tight, getting stuck at the very distal end of the ankle clamp.Scratches appeared on the inner metal work of the up rod.Please see images.¿ the product was not returned to medtech orthopaedics; however, photos were provided for review.See attachment ¿(b)(4) - damaged new attune instrument¿.Review of the photographic evidence revealed that the inertial surface of the attune em tibial dist uprod presents signs of scratching.However, no evidence was provided to indicate that the instrument was jammed; additionally, functionality issues cannot be assessed through photo investigation.The observed condition of the device was consistent with a random component failure, potentially caused by exposure to unintended forces such as heavy usage or misaligned assembly/disassembly with its mating instrument.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the attune em tibial dist uprod would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE EM TIBIAL DIST UPROD
• Common Device Name: ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
• 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: 22386405
• Report Number: 1818910-2025-11206
• Device Sequence Number: 15623353
• Product Code: LXH
• UDI-Device Identifier: 10603295129752
• UDI-Public: (01)10603295129752(10)PG344929
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,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: 254400003
• Device Lot Number: PG344929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2021
• 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