BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3203469 · Received July 2, 2013

    Report

    Report Number
    8030965-2013-04186
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SYNTHES LOT NUMBER IS 5133658.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY (B)(4). THE CUSTOMER'S COMPLAINT OF NOT WORKING WAS NOT CONFIRMED. THE SMALL BATTERY DRIVE WAS EVALUATED AND THE DEVICE FUNCTIONED WHEN POWER WAS APPLIED. THE CUSTOMER'S COMPLAINT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    FACILITY REPORTS DURING ORIF OF RIGHT FOREARM, THE SMALL BATTERY DRIVE DID NOT FUNCTION. IT IS REPORTED A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM, NO DELAY IN PROCEDURE, AND NO REPORTED HARM TO PATIENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301319 SMALL BATTERY DRIVE HWE SYNTHES GMBH 5133658

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR