BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.5CM ANGLE ATTACHMENT

    MDR report key: 4161862 · Received October 10, 2014

    Report

    Report Number
    1045834-2014-13758
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    March 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

    THE DEVICE RETURNED FOR SERVICE DURING THE EVALUATION THE TECHNICIAN FOUND THAT THE HOUSING WAS DAMAGED AND DISCOLORED DUE TO IMPROPER CLEANING AND MAINTENANCE. THIMBLE COLOR LINES NOT VISIBLE ANYMORE. BEARING DEFECTIVE AND GEAR WHEEL WORN OUT. THE DEVICE WAS SUBSEQUENTLY REPAIRED AND RETURNED TO THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. THE DEVICE RETURNED FOR SERVICE DURING THE EVALUATION THE TECHNICIAN FOUND THAT THE LOCKING COMPONENTS WERE DAMAGED. THE DEVICE WAS SUBSEQUENTLY REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR SERVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639870 7.5CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1