BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILL-SAW

    MDR report key: 4097170 · Received September 17, 2014

    Report

    Report Number
    8030965-2014-01319
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Report Date
    October 18, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    EWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, FOUND THAT THE DEVICE HAS NOT BEEN PROPERLY MAINTENANCE OR SERVICED AND THE POOR PERFORMANCE WAS DUE TO NORMAL WEAR. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SAW OFTEN STICKS DURING THE FEMORAL HEAD SURGERY. THE SAW PERFORMANCE WAS WEAKER COMPARED TO A SECOND IDENTICAL SAW. THIS IS REPORT 1 OF 1 FOR EVENT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574428 OSCILL-SAW EWQ SYNTHES GMBH 6406

    Patients

    Seq Age Sex Outcome Treatment
    1