BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 HAND CONTROL

    MDR report key: 3213203 · Received July 9, 2013

    Report

    Report Number
    1045834-2013-02685
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 13, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THE CUSTOMER DID NOT ALLEGE A SPECIFIC MALFUNCTION. DURING PRE-TESTING, IT WAS OBSERVED THAT THE DEVICE WAS MISSING BOTH O-RINGS. RELIABILITY ENGINEERING EVALUATED THE DEVICE. A FUNCTIONAL ASSESSMENT REVEALED THAT THE MOTOR COULD NOT BE ATTACHED. EVIDENCE INDICATES THIS WAS DUE TO NORMAL WEAR OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL FUSION SURGICAL PROCEDURE THE HAND CONTROL DEVICE WAS "SLIDING ON THE MOTOR DEVICE" AND WOULD NOT STAY ATTACHED". THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITHOUT DELAY AS A SPARE IDENTICAL DEVICE WAS AVAILABLE FOR USE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS ALLEGED. 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
    312966 EMAX 2 HAND CONTROL MOTOR, DRILL, ELECTRIC-HAND CONTROL HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1 MOTOR DEVICE