BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA® JARIT®

    MDR report key: 23735743 · Received December 8, 2025

    Report

    Report Number
    23735743
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 4, 2025
    Manufacturer
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    Product Code
    HXS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY [REDACTED DATE]. POST-OP IMAGING NOTED A RETAINED FOREIGN BODY. THE PATIENT RETURNED TO THE OR ON [DATE REDACTED] - THE NEXT DAY - FOR REMOVAL OF THE RETAINED ITEM, WHICH WAS NOTED TO BE A PIECE OF THE NEEDLE HOLDER. THE AFFECTED NEEDLE HOLDER HAS BEEN LOCATED AND REMOVED FROM SERVICE. THE NEEDLE HOLDER BROKE OFF WITHIN THE PATIENT DURING THA REQUIRING AN ADDITIONAL PROCEDURE TO REMOVE. DEVICE IDENTIFIERS JARIT OR INTEGRA-JARIT #121-260 TUNGSTEN CARBIDE CARB-BITE NEEDLE HOLDER 7.5." OTHER IDENTIFIERS ON THE INSTRUMENT INCLUDE: [REDACTED]. MAY ALSO BE KNOWN AS MAYO-HEGAR NEEDLE HOLDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130944 INTEGRA® JARIT® TWISTER, WIRE HXS INTEGRA LIFESCIENCES PRODUCTION CORPORATION 121260

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other