BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS POWER SAGITTAL SAW

    MDR report key: 5250292 · Received November 25, 2015

    Report

    Report Number
    1643264-2015-00183
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Date of Event
    February 13, 2013
    Report Date
    February 22, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE WAS RECEIVED AND CONFIRMED OF NO OPERATION. DEVICE WAS SENT FOR FURTHER EVALUATION WHERE IT WAS ADDITIONALLY CONFIRMED THAT THE DEVICE DID NOT FUNCTION. DEVICE HAD TRANSMISSION, MOTOR, BEARINGS, WASHERS, O-RINGS, AND RETAINERS REPLACED. AFTER THE EVALUATION THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    DURING AN UNKNOWN PROCEDURE IT WAS REPORTED THAT THE MOTOR OF THE DEVICE DIDN'T START TO ROTATE BECAUSE OF THE TROUBLE WITH THE HANDLE SWITCH. IT WAS CONFIRMED THAT THE HANDLE SWITCH DIDN'T WORK WHILE THE DEVICE COULD BE STARTED TO ROTATE WITH THE FOOTSWITCH. THERE WAS A REPORTED ONE HUNDRED FIFTY MINUTE DELAY AND NO PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779035 DYONICS POWER SAGITTAL SAW SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. VO002614

    Patients

    Seq Age Sex Outcome Treatment
    1