BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5CM ADULT CRANI ATTACHMT

    MDR report key: 6142457 · Received December 2, 2016

    Report

    Report Number
    1045834-2016-13351
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Report Date
    July 26, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(4). THE DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. IT WAS ALSO NOTED THAT THE DEVICE HAD WORN OUT BEARINGS CAUSING THE DEVICE TO FAIL CUTTER INSERTION TEST. IT WAS DETERMINED THAT THIS WAS CONSISTENT WITH NORMAL WEAR OVER TIME. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD A DRILLED NEURO TIP WHICH WAS CONSISTENT WITH FAILURE TO FOLLOW THE DIRECTIONS FOR USE. IT WAS DETERMINED THAT WHEN THE BURR DEVICE WAS IMPROPERLY LOADED INTO THE ATTACHMENT DEVICE AND THEN INSTALLED ONTO THE DRILL DEVICE, THE BURR DID NOT SEAT PROPERLY IN THE LOCKING CHAMBER. IT WAS DETERMINED THAT THE ATTACHMENT DEVICE COULD BE FORCED INTO POSITION WHICH PLACED THE DISTAL TIP OF THE BURR IN COMPRESSION. AT THIS POINT, THE TIP OF THE BURR WAS IN DIRECT CONTACT WITH THE NEURO TIP OF THE ATTACHMENT. WHEN THE DRILL WAS STARTED, THE BURR DRILLED INTO OR THROUGH THE NEURO TIP. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO USER ERROR AND NORMAL WEAR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) THAT THE CRANIOTOME DEVICE HAD AN UNDETERMINED MALFUNCTION. DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT THE DEVICE FAILED CUTTER INSERTION TEST DUE TO WORN OUT BEARINGS. IT WAS ALSO NOTED THAT THE DEVICE HAD A DRILLED NEURO TIP, CORROSION AND FAILED CUTTER INSERTION TEST . THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793905 6.5CM ADULT CRANI ATTACHMT MOTOR, DRILL, ELECTRIC - CRANIOTOME HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1