BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 2991339 · Received March 6, 2013

    Report

    Report Number
    8030965-2013-00756
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED OR DUPLICATED; THE UNIT WAS TESTED AND PASSED ALL OPERATIONAL SPECIFICATIONS, AND NO PROBLEMS WERE NOTED.

    Description of Event or Problem · 1

    ON THE (B)(6) 2013, DURING A FINGER PROCEDURE, THE SMALL BATTERY DRIVE KEPT LOSING POWER. THE DRIVE WAS USED WITH TWO DIFFERENT BATTERIES BUT, STILL LOST POWER. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE USING THE DEVICE. NO HARM TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95317 SMALL BATTERY DRIVE HWE SYNTHES GMBH 002700

    Patients

    Seq Age Sex Outcome Treatment
    1