BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 3503132 · Received December 6, 2013

    Report

    Report Number
    8030965-2013-05448
    Event Type
    Malfunction
    Date Received
    December 6, 2013
    Date of Event
    November 5, 2013
    Report Date
    November 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DZI, ERL, HBE: ADDITIONAL CODES. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO (B)(4) SERVICE AND REPAIR: DURING A PRODISC CERVICAL PROCEDURE ON (B)(6) 2013, THE ELECTRIC PEN DRIVE WOULD NOT TURN OFF UNLESS THE HAND PIECE WAS SWITCHED TO LOCK. THERE WAS A DELAY BETWEEN FIVE AND TEN MINUTES BECAUSE THERE WASN'T A SPARE DEVICE AVAILABLE. IT WAS REPORTED THAT THE INCIDENT WAS NOT RELATED TO A SPECIFIC PATIENT SO NO PATIENT INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635172 ELECTRIC PEN DRIVE 60,000 RPM HWE SYNTHES GMBH 3041

    Patients

    Seq Age Sex Outcome Treatment
    1