BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSITOMIC ACL FLEXIBLE GUIDE PIN

    MDR report key: 12307610 · Received August 10, 2021

    Report

    Report Number
    MW5103159
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    August 3, 2021
    Report Date
    August 8, 2021
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GFG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VERSITOMIC ACL FLEXIBLE REAMER SYSTEM FLEXIBLE GUIDE PIN (STRYKER) REF 234-108-200, LOT 19P01, EXP 05-04-2024. PIECE OF FLEXIBLE GUIDE PIN BROKE INSIDE PATIENT. INTRA-OP XRAY WAS TAKEN AND WAS SHOWN THAT IT IS IN THE BONE (RIGHT KNEE). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197883 VERSITOMIC ACL FLEXIBLE GUIDE PIN BIT, SURGICAL GFG STRYKER INSTRUMENTS 234-108-200 19P01

    Patients

    Seq Age Sex Outcome Treatment
    1