BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO LOW PRESSURE

    MDR report key: 4183070 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14273
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    May 20, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBB
    PMA / PMN Number
    PK831756
    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. (B)(6). DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED RPM WAS BELOW SPECIFICATION. THIS WAS ATTRIBUTED TO DEFECTIVE DESIGN. VARIOUS PARTS WERE REPLACED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPLACED SEVERAL COMPONENTS. PRE-REPAIR ASSESSMENT SHOWED LOW RPM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660265 BLACKMAX-NEURO LOW PRESSURE MOTOR, DRILL, PNEUMATIC - HANDPIECE HBB DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1