BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11CM ANGLE ATTACHMENT

    MDR report key: 4153412 · Received October 8, 2014

    Report

    Report Number
    1045834-2014-13321
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    March 27, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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, INVESTIGATION REVEALED THE DEVICE HAS A DEFECTIVE BEARING AND GUIDE TUBE. THE DEVICE WAS REPAIRED AND RETURNED TO CUSTOMER ON (B)(4) 2013. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE TOP OF DEVICE OVERHEATS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631320 11CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1