BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEMORY

    MDR report key: 5359674 · Received January 12, 2016

    Report

    Report Number
    5359674
    Event Type
    Malfunction
    Date Received
    January 12, 2016
    Date of Event
    December 30, 2015
    Report Date
    January 7, 2016
    Manufacturer
    HOWMEDICA OSTEONICS CORP., AKA STRYKER ORTHOPAEDICS
    Product Code
    JDR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE ARTHROSCOPY PROBE, THE PROBE BENT AND BROKE LEAVING THE TIP IN THE KNEE. IT WAS SUCCESSFULLY RETRIEVED BY THE SURGEON PRIOR TO CLOSURE WITHOUT HAVING TO MAKE A NEW INCISION. MANUFACTURER RESPONSE FOR ARTHROSCOPY PROBE, (BRAND NOT PROVIDED) (PER SITE REPORTER): UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20254 MEMORY STAPLE, FIXATION, BONE JDR HOWMEDICA OSTEONICS CORP., AKA STRYKER ORTHOPAEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1