BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    MDR report key: 3577115 · Received November 14, 2013

    Report

    Report Number
    8031000-2013-00335
    Event Type
    Malfunction
    Date Received
    November 14, 2013
    Date of Event
    October 15, 2013
    Report Date
    October 15, 2013
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING A PERSONA KNEE SAWBONES LAB IN THE OFFICE WITH THE OFFICE'S UNIVERSAL OSCILLATING SAW ATTACHMENT DEMO SET, THE OSCILLATING SAW BROKE. THE OSCILLATING SAW STOPPED OSCILLATING EVEN THOUGH THE BATTERY WAS STILL WORKING. THE SAW ATTACHMENT WAS INSPECTED, REVEALING THAT THE "TEETH" WHICH ENGAGE THE BLADE HAD BEEN SHEARED OFF. ONLY 2 "TEETH" REMAINED ON THE OSCILLATING SAW, BOTH IN THE REAR PORTION OF THE SAW THAT DOES NOT ENGAGE A SAW BLADE. SALES REPRESENTATIVE SPECULATED THAT POSSIBLY NOT ALL OF THE "TEETH" WERE SHEARED DURING THE EVENT AND THAT SOME OF THE TEETH MAY HAVE BEEN MISSING FROM PREVIOUS USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591177 UNIVERSAL OSCILLATING SAW ATTACHMENT UNIVERSAL OSCILLATING SAW ATTACHMENT GEY ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1