BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING SAW ATTACHMENT

    MDR report key: 3941048 · Received July 17, 2014

    Report

    Report Number
    8030965-2014-00434
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    May 23, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES (B)(6) 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(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE PART WAS RETURNED AND INSPECTED. DURING THE INSPECTION THE TECHNICIAN FOUND THE COUPLING POWER SUPPLY WAS DAMAGED AND NOT FUNCTIONING. THE NOTED OBSERVATIONS ARE DUE TO FAULTY HANDLING. DEVICE REPAIRED AND SENT TO CUSTOMER ON (B)(6) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DIFFICULTY WITH ATTACHING THE HAND PIECE, AND THE BODY HEATED UP WITH KEY. THERE WAS NO REPORT OF INJURY TO PATIENT OR USER. THIS IS 1 OF 1 REPORT FOR #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419178 OSCILLATING SAW ATTACHMENT HWE SYNTHES GMBH 6829

    Patients

    Seq Age Sex Outcome Treatment
    1