BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.5CM LARGE CRANIOTOME ATTCH

    MDR report key: 4180307 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-13183
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    January 30, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK133604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, IT WAS NOTED THAT THE NEURO TIP AND THE BEARINGS WERE DAMAGED. THE ROOT CAUSE IS UNDETERMINED. NO ADDITIONAL INFORMATION AT THIS TIME. DEVICE WAS INSPECTED, AND REPAIRED BY REPLACING A FEW COMPONENTS.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR SERVICE. DURING THE PRE-ASSESSMENT THE TECHNICIAN FOUND THAT THE NEURO TIP BROKEN AND THE BEARINGS WERE DAMAGED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662967 7.5CM LARGE CRANIOTOME ATTCH MOTOR, DRILL, ELECTRIC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1