BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11CM ANGLE ATTACHMENT

    MDR report key: 4170946 · Received October 14, 2014

    Report

    Report Number
    1045834-2014-13974
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    May 15, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES (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.

    Additional Manufacturer Narrative · 1

    DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE DEVICE HAD MULTIPLE PARTS REQUIRING REPLACEMENT. ABOVE-SPECIFICATION TEMPERATURE WAS ALSO FOUND. THIS WAS ATTRIBUTED TO IMPROPER MAINTENANCE. VARIOUS PARTS WERE REPLACED. DEVICE WAS REPLACED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR AN UNSPECIFIED REASON. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649902 11CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1