MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE CR FEM TRIAL SZ 5 RT; FEMORAL TRIALS

Catalog Number	254500705
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the posterior condyle part of the trial device broke off when the trial was impacted onto the patients femur.It was reported that another set was opened.There were no patient consequences due to the event.It was reported that the procedure was prolonged by three minutes.All available information has been disclosed.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Investigation summary: according to the information received that the posterior condyle part of the trial broke off when the trial was impacted onto the patient's femur.The product was not returned to depuy synthes; however, photos were provided for review.(b)(4).The photo investigation revealed that '254500705, attune cr fem trial sz 5 rt has condyle broken."the fracture surface is consistent with overload due to a combination of heavy impaction and the trial fitting too tight over the posterior/anterior aspect of the resected femur bone forcing the curved features of the femoral trial to open.The combination of heavy impaction and possible discrepancies in the resection depth between the femur and the trial suggest unintended user error.Furthermore, per the attune surgical technique (dsus/jrc/0316/1437 rev.K) it is cautioned when extracting the trial, rocking the trial medio-laterally may cause condylar fracture.Such rocking should be avoided." since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune cr fem trial sz 5 rt would contribute to the complained device issue.Based on the investigation findings, the femoral trial has broken because of unintended user 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 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: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the lot code provided is not a valid finished goods lot.

• Brand Name: ATTUNE CR FEM TRIAL SZ 5 RT
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23544183
• Report Number: 1818910-2025-19744
• Device Sequence Number: 9284368
• Product Code: HWT
• UDI-Device Identifier: 10603295133773
• UDI-Public: (01)10603295133773(10)MVMKNH790
• 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,User Facility,Company Representative
• 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: 254500705
• Device Lot Number: (10)MVMKNH790
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 02/01/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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