BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-N-LP

    MDR report key: 4183259 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14563
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    January 21, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBB
    PMA / PMN Number
    PK831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 FOUND A DAMAGED COVER WAS FOUND DUE NORMAL WEAR. THERE WERE ALSO A DAMAGED RING, BROKEN SPIKE, DEFECTIVE FASTENER, AND DEVICE WOULD GET HOT. THE DEVICE WAS REPAIRED, SOME PARTS WERE REPLACED. MANUFACTURING DATE FOR THIS DEVICE IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED IT RUNS EVEN WHEN IT IS UNLOCKING. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660742 BLACKMAX-N-LP BLACKMAX-NEURO LOW PRESSURE HBB DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1