BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX

    MDR report key: 4938416 · Received July 6, 2015

    Report

    Report Number
    4938416
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 3, 2015
    Report Date
    July 6, 2015
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING A LUMBAR FUSION CASE, THE DR USING THE ANSPACH DRILL CABLE HAD A HOLE BLOW OUT IN IT, APPROXIMATELY 4 INCHES LONG. THIS CAUSED AN EXTREMELY LOUD "POP" AND A DELAY IN THE CASE AS NEW EQUIPMENT NEEDED TO BE BROUGHT TO THE ROOM.THE HOSE USED WITH THE DRILL CONTAINS AN INNER NYLON, BRAIDED COVER THAT PROTECTS THE INNER LUMEN. THERE IS ALSO AN OUTER RUBBER SHEATH THAT COVERS THE BRAIDED CABLE HOSE. IT IS THE OUTER RUBBER COVER THAT RUPTURED.IT IS NOT CLEAR IF THE RUBBER COVER IS THERE TO INDICATE POTENTIAL GAS LEAKS WHILE USING THE DRILL. THERE MUST HAVE BEEN SOME GAS LEAKAGE FROM THE INNER TUBING THAT BUILT UP PRESSURE WHILE USING THE DRILL CAUSING PRESSURE TO EXCEED THE RATING OF THE RUBBER COVER. ULTIMATELY, LEADING TO THE RUPTURE.======================MANUFACTURER RESPONSE FOR HIGH SPEED PNEUMATIC SURGICAL DRILL, SYNTHES ANSPACH XMAX PNEUMATIC SYSTEM (PER SITE REPORTER).======================AS OF THIS REPORT THERE HAS BEEN NO RESPONSE FROM THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437117 XMAX INSTRUMENT, SURGICAL, ORTHOPEDIC PNEUMATIC HSZ THE ANSPACH EFFORT, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR