BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING BONE SAW DOUBLE HOSE CONNECTOR

    MDR report key: 3920187 · Received July 8, 2014

    Report

    Report Number
    8030965-2014-00417
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Report Date
    January 16, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. 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. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE POWER WAS LOW. THIS WAS CONTRIBUTED TO NORMAL WEAR. UNIT WAS REPAIRED AND RETURNED ON (B)(6) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING AN OPERATION THERE WAS A LACK OF POWER WITH THE DEVICE. THIS IS 1 OF 1 REPORT FOR #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397479 OSCILLATING BONE SAW DOUBLE HOSE CONNECTOR HWE SYNTHES GMBH 8090

    Patients

    Seq Age Sex Outcome Treatment
    1