BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR DRIVER WITH HUDSON END

    MDR report key: 4180601 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14355
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    January 2, 2013
    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

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO (B)(4) AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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, THE FUNCTIONAL TESTING REVEALED THAT THE DEVICE DID NOT FUNCTION PROPERLY. THE DEVICE WAS REPAIRED BY REPLACING SEVERAL COMPONENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DEVICE HAD NO POWER AND SLUGGISH. THIS IS REPORT 1 OF 1 FOR COMPLAINT COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663202 PERFORATOR DRIVER WITH HUDSON END DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1