MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATT PATELLA CLAMP POR; KNEE INSTRUMENT: CLAMPS

Catalog Number	254511041
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
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.Additional narrative: h3, h6: product investigation summary: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned device found that the att patella clamp por had the t-handle broken, the broken fragment was returned for evaluation.The fracture characteristics are consistent with torsional overload from over tightening the clamp while securing the patella.No evidence of material or manufacturing defects were found that could have contributed to the initiation or propagation of the fracture to failure.Per the attune fixed bearing porous knee surgical technique pages 72-74, the surgeon is instructed to use one hand to position the clamp centralized over the implant and in the correct alignment, while using the other hand to slowly rotate the t-handle clockwise while observing uniform seating of the implant until full seating is achieved.Full seating is achieved when the metal surface is in direct contact with the bone, however, when the patella is fully seated, there may be a slight gap between the polyethylene back and the surface of the bone which is acceptable.Using two hands or excessive torque may indicate an issue with the bone preparation or seating alignment and could cause damage to the instrument (as observed with the returned broken t-handle) or bone.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the att patella clamp por would have contributed to a device issue.Based on the investigation findings, the potential cause is traced to unintended use error, and 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 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.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
The device was reported for unknown reason.The event did not happen in surgery.During manufacturer's investigation of the returned device it was identified that the att patella clamp por had the t-handle broken.

• Brand Name: ATT PATELLA CLAMP POR
• Common Device Name: KNEE INSTRUMENT: CLAMPS
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24574836
• Report Number: 1818910-2026-04572
• Device Sequence Number: 21413973
• Product Code: HWN
• UDI-Device Identifier: 10603295499213
• UDI-Public: (01)10603295499213(10)10603295499213
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 254511041
• Device Lot Number: PC5127455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2021
• 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