BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDE RASP HANDLE

    MDR report key: 5354489 · Received January 8, 2016

    Report

    Report Number
    0009617544-2016-00014
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Date of Event
    December 17, 2015
    Report Date
    December 17, 2015
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    PMA / PMN Number
    N/A -CLASS I
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT# 134002. VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; THE AGE OF THE DEVICE (3 YEARS) AND ACCORDING TO THE SALES REP THE DEVICE HAD BEEN USED 200-300 HUNDRED TIMES. THE PLAUSIBLE ROOT CAUSE IS NORMAL WEAR BASED ON AGE AND EXTENSIVE USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE HANDLE SNAPPED OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE HANDLE SNAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14326 SLIDE RASP HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT. LXH STRYKER SPINE-FRANCE 134002

    Patients

    Seq Age Sex Outcome Treatment
    1