BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 4181311 · Received October 17, 2014

    Report

    Report Number
    2520274-2014-14216
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 3, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION WAS UNKNOWN. THE DEVICE MANUFACTURE DATE IS UNKNOWN. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO VARIOUS WORN COMPONENTS AND BEARINGS DETERIORATION DUE TO WEAR FROM NORMAL USE AND SERVICING. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED VETERINARY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE WAS SPINNING. AS A RESULT, THERE WAS A FIVE MINUTE DELAY TO THE SURGICAL PROCEDURE. THERE WAS AN IDENTICAL SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS WAS A VETERINARY SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661105 SAGITTAL SAW ATTACHMENT INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 100215

    Patients

    Seq Age Sex Outcome Treatment
    1