BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND SWITCH FOR ELECTRIC PEN DRIVE

    MDR report key: 3151584 · Received June 7, 2013

    Report

    Report Number
    8030965-2013-02834
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS RECEIVED FOR EVALUATION. THE REPORTER'S COMPLAINT THAT THE HAND SWITCH FOR ELECTRIC PEN DRIVE WILL NOT WORK COULDN'T BE CONFIRMED. THE DEVICE WAS TESTED AND THE COMPLAINT WASN'T DUPLICATED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A SERVICE HISTORY OF THE PAST SIX MONTHS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN SENT IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS DURING A DISTAL RADIOULNAR JOINT ARTHROPLASTY PROCEDURE ON (B)(6) 2013, THE ELECTRIC PEN DRIVE AND HAND SWITCH FOR ELECTRIC PEN DRIVE OPERATED IN THE LOCKED POSITION AND THEN STOPPED WORKING COMPLETELY. REPORTEDLY THE PROCEDURE WAS DELAYED APPROXIMATELY 3 MINUTES WHILE A SPARE DEVICE WAS RETRIEVED. THE SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM. NO HARM TO THE PATIENT WAS REPORTED. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252281 HAND SWITCH FOR ELECTRIC PEN DRIVE HWE SYNTHES GMBH AV18166

    Patients

    Seq Age Sex Outcome Treatment
    1