BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    MDR report key: 3915809 · Received June 12, 2014

    Report

    Report Number
    8031000-2014-00262
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    March 14, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    UNIVERSAL OSCILLATING SAW ATTACHMENT (B)(4) WAS RETURNED FOR COMPLAINT INVESTIGATION. UPON RECEIPT, IT WAS CONFIRMED THAT SOME PINS WERE NO LONGER ATTACHED TO THE MOUNTED DRIVE SHAFT. NO OTHER EXTERNAL DAMAGE WAS OBSERVED. THE DEVICE HAS BEEN REPAIRED AND RETURNED. THE ROOT CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOCKING MECHANISM FOR THE UNIVERSAL OSCILLATING SAW ATTACHMENT CAN NOT BE UNSCREWED. THERE WAS NO PT HARM; HOWEVER THERE WAS A DELAY IN SURGERY FOR APPROX 10 MINUTES. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346807 UNIVERSAL OSCILLATING SAW ATTACHMENT UNIVERSAL OSCILLATING SAW ATTACHMENT GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1