BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWDRIVER

    MDR report key: 21230639 · Received January 24, 2025

    Report

    Report Number
    3010536692-2025-00015
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    December 31, 2024
    Report Date
    December 26, 2025
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HXX
    UDI-DI
    M684184101351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Additional Manufacturer Narrative · 0

    THE ALLEGED COMPLAINT IS CONFIRMED. THE PRODUCT WAS RETURNED FOR INVESTIGATION. EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THAT IT HAD SUSTAINED DAMAGE. THE HEX TIP HAD FRACTURED AND WAS STUCK IN THE MATING COMPONENT OF THE STEM EXTRACTOR. IT IS LIKELY THAT HEX GEOMETRY HAD SUSTAINED DAMAGE AND BECAME STUCK LEADING TO FRACTURE UNDER FORCE. THE INSTRUMENTS WERE WELL WORN AND OLD JUDGING FROM THE APPEARANCE AND LOT NUMBERS. THE HEX EDGES CAN WEAR OF YEARS OF USE, AND THIS ISSUE IS LARGELY UNAVOIDABLE OVER THE LIFETIME OF THE INSTRUMENT. THIS INSTRUMENT WAS PURCHASED IN 2006. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT INDICATES THAT THIS PRODUCT MET ALL ACCEPTANCE CRITERIA AT THE TIME OF MANUFACTURING. THERE WERE NO TRENDS IDENTIFIED FOR THIS INSTRUMENT AND COMPLAINT TYPE. THIS IS THE ONLY COMPLAINT FOR THIS LOT AND THE FIRST COMPLAINT FOR THE PRODUCT SINCE 2022. THE MICROPORT INSTRUMENT CLEANING AND HANDLING INSTRUCTIONS (150802) INDICATE THAT THE INSTRUMENTS ARE SUSCEPTIBLE TO DAMAGE OVER TIME AND SHOULD BE INSPECTED PRIOR TO AND AFTER EACH USE. IN ADDITION, THE CLEANING AND HANDLING INSTRUCTIONS ALSO STATE, "END OF FUNCTIONAL LIFE IS NORMALLY DETERMINED BY WEAR AND DAMAGE DUE TO USE." THIS COMPLAINT IS ADDRESSED BY WD014283 - COMMON INSTRUMENT FAILURE MODES MEMO. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH COMPLAINT TRACKING.

    Description of Event or Problem · 0

    ALLEGEDLY, SCREWDRIVER BROKE OFF IN THE STEM EXTRACTOR. SURGERY WAS EXTENDED GREATER THAN 30 MINUTES.

    Description of Event or Problem · 0

    ALLEGEDLY, SCREWDRIVER BROKE OFF IN THE STEM EXTRACTOR. THE SURGERY WAS EXTENDED GREATER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556438 SCREWDRIVER KNEE INSTRUMENT HXX MICROPORT ORTHOPEDICS INC. 18410135 332719 M684184101351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention