BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 3232667 · Received July 18, 2013

    Report

    Report Number
    2520274-2013-04414
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 20, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED, DATE NOT PROVIDED. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN SENT IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, THERE WAS NO INJURY, THE DEVICE ON THE MAYO STAND BEGAN TO TURN ON AT A VERY LOW RPM.

    Description of Event or Problem · 1

    DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2013, REPORTEDLY THE ELECTRIC PEN DRIVE WOULD NOT STOP RUNNING. THE FACILITY CONFIRMS IT WAS NECESSARY TO DISCONNECT THE DEVICE FROM THE POWER SOURCE. IT WAS REPORTED A SPARE DEVICE WAS AVAILABLE AND WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM. NO HARM TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334615 ELECTRIC PEN DRIVE 60,000 RPM HWE SYNTHES USA 4938

    Patients

    Seq Age Sex Outcome Treatment
    1