BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 CM ANGLE ATTACHMENT

    MDR report key: 4183177 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14351
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    August 14, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES 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, THE FUNCTIONAL TESTING REVEALED THAT DEVICE GETS HOT, ABOVE TEMPERATURE SPECIFICATIONS. IT WAS ALSO NOTED THAT THERE WAS DETERGENT RESIDUE AND RUST PRESENT. IMPROPER CLEANING AND MAINTENANCE WERE ATTRIBUTED TO THE REPORTED CONDITION. THE DEVICE WAS REPAIRED BY REPLACING SEVERAL COMPONENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DEVICE DID NOT FUNCTION PROPERLY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660301 8 CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1