MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SPECIALIST*2 UNIVERSAL HANDLE; KNEE INSTRUMENT : HANDLES

Catalog Number	966520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: 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
It was reported during a knee surgery, a flying particle of the femoral impactor has injured the nurse in her chest.No surgical delay.The nurse had a right-sided thoracal punctured wound foreign body.The patient had flushing of the wound and bandage applied and a tetanus vaccine was given.The torn part is still inside the injured nurse's body, as its surgery is complicated, and it may remain there.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: according to the information received, "during a knee surgery, a flying particle of the femoral impactor has been injured the nurse in her chest" the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found a portion of the base of the device is chipped.The chipping of the handle is consistent with repeated off-axis impacts, when the surgeon strikes the base of the handle while seating the tibial trial construct.Properly handling and attention to the approved use of the device diminishes the risk of failure.Additionally, signs of intensive use are visible on the specialist*2 universal handle.Worn condition observed can be attributed to an end of life problem, damage consistent with repeated use and servicing (the device is 20+ years old).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 specialist*2 universal handle would have contributed to the complained 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: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (j1002) provided is not a valid finished goods lot number.Corrected: h3.

• Common Device Name: KNEE INSTRUMENT : HANDLES
• 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: 22336323
• Report Number: 1818910-2025-10636
• Device Sequence Number: 13016027
• Product Code: LXH
• UDI-Device Identifier: 10603295248644
• UDI-Public: (01)10603295248644(10)J1002
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 966520
• Device Lot Number: J1002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown