MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATUNE REV ASMBLY OFST STABLIZR; KNEE INSTRUMENTS: ALIGNMENT DEVICE

Catalog Number	254600422
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During use of the stabilizer, there is a knob (highlighted in red in the photo).This knob is used to tighten and hold the final prosthesis in place for assembly.This knob is very tight and difficult to loosen or tighten, hindering assembly.To do so, it was necessary to use a wrench and apply considerable force.Tightening and loosening it should be done gently, using only the fingers, to achieve this rotation.This knob must be replaced because eventually it will stop turning, or the internal threads will break due to excessive force, preventing proper implant assembly.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: according to the information received "during use of the stabilizer, there is a knob (highlighted in red in the photo).This knob is used to tighten and hold the final prosthesis in place for assembly.This knob is very tight and difficult to loosen or tighten, hindering assembly.To do so, it was necessary to use a wrench and apply considerable force.Tightening and loosening it should be done gently, using only the fingers, to achieve this rotation.This knob must be replaced because eventually it will stop turning, or the internal threads will break due to excessive force, preventing proper implant assembly.¿.The product was not returned to depuy synthes; however, photos were provided for review.See attachment ¿source file - novedad colsubsidio roma 570660¿ the device associated with this report was not returned to medtech orthopedics for evaluation.The photographs attached were reviewed, however the provided evidence was not sufficient to confirm the reported event of loose.Functionality issues cannot be evaluated through a photo investigation.The overall complaint was unconfirmed as the photographs attached don¿t have any evidence to draw a conclusion about the reported event.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 complaint condition.As part of medtech orthopedics 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: ATUNE REV ASMBLY OFST STABLIZR
• Common Device Name: KNEE INSTRUMENTS: ALIGNMENT DEVICE
• 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: 23544271
• Report Number: 1818910-2025-19747
• Device Sequence Number: 15874050
• Product Code: LXH
• UDI-Device Identifier: 10603295440352
• UDI-Public: (01)10603295440352(10)GM6176409
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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: 254600422
• Device Lot Number: GM6176409
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• 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