MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE EM TIBIAL ANKLE CLAMP; KNEE INSTRUMENT: CLAMPS

Catalog Number	254400001
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
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 medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found signs of heavy usage on its overall surface.No other cosmetic anomaly was identified on its surface.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was performed using the device mechanism.After actuating all components, test revealed device had resistance while moving its locking mechanism.Although the condition observed can be caused by improper lubrication, a foreign matter trapped inside the internal components, or by a possible internal damage, taking in consideration the aspect and age of the device (around 14 years), the observed condition was identified as an end-of-life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.The overall complaint was confirmed as the observed condition of the attune em tibial ankle clamp would have contributed to a 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 depuy synthes 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: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code pg0411 provided is not a valid finished goods lot number.
Event or Problem Description
Instruments were reported for unknown reason.It did not happen in surgery.

• Brand Name: ATTUNE EM TIBIAL ANKLE CLAMP
• Common Device Name: KNEE INSTRUMENT: CLAMPS
• 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: 24617265
• Report Number: 1818910-2026-04899
• Device Sequence Number: 13345648
• Product Code: HXD
• UDI-Device Identifier: 10603295129738
• UDI-Public: (01)10603295129738(10)PG0411
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 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: 254400001
• Device Lot Number: PG0411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2011
• 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