BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 2991335 · Received March 6, 2013

    Report

    Report Number
    8030965-2013-00755
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 6, 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
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM WAS CONFIRMED DURING TESTING. THE UNIT EXHIBITED DAMAGE TO THE MOTOR - ECU THAT WAS CONSISTENT WITH IMMERSION IN WATER. THIS CONDITION IS INDICATIVE OF IMPROPER CLEANING OF THE DEVICE. WE RECOMMEND THAT THE USER REVIEW THE CLEANING AND MAINTENANCE PROCEDURES FOR THE DEVICE. PROPER CLEANING AND MAINTENANCE ARE REQUIRED IN ORDER TO ENSURE TROUBLE-FREE OPERATION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, WHEN THE BATTERY WAS INSERTED INTO THE SMALL BATTERY DRIVE, IT SPUN WITHOUT BEING TRIGGERED. THE PRODUCT WAS NOT USED IN SURGERY. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM TO USER 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
    96200 SMALL BATTERY DRIVE HWE SYNTHES GMBH 001964

    Patients

    Seq Age Sex Outcome Treatment
    1