BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10.5CM ANGLE ATTACHMENT, BLACK MAX

    MDR report key: 4183160 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14297
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 26, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. THE DEVICE WAS RECEIVED FOR INSPECTION. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED BALL BEARINGS IN EXTENSION SLEEVE WERE RUSTED AND DAMAGED. THE DEVICE OVERHEATED AND FAILED VIBRATION TEST. THIS ATTRIBUTED TO IMPROPER MAINTENANCE. THE DEVICE WAS REPAIRED AND RETURNED TO CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER RETURNED THE DEVICE FOR SERVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660652 10.5CM ANGLE ATTACHMENT, BLACK MAX DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1