BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3161385 · Received June 11, 2013

    Report

    Report Number
    1045834-2013-02397
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 17, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. ALTHOUGH THE INITIAL REPORT DID NOT IDENTIFY ANY DEFICIENCY, IT WAS OBSERVED DURING THE DEVICE EVALUATION OF THE MOTOR DEVICE THAT THE SET SCREWS WERE WORN OUT. EVIDENCE INDICATES THIS IS DUE TO USAGE WEAR OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR DEVICE HAD AN UNKNOWN MALFUNCTION. IT WAS UNKNOWN TO THE REPORTER WHEN THE ALLEGED DEFECT OCCURRED. IT WAS UNKNOWN TO THE REPORTER IF THE DEVICE WAS USED IN SURGERY, IF THERE WAS A DELAY IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS UNKNOWN TO THE REPORTER IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THE EXACT EVENT DATE WAS UNKNOWN. HOWEVER, THE REPORTER INDICATED THE EVENT OCCURRED IN (B)(6) 2013. 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
    263053 XMAX MOTOR DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC-HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1