BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE CASING FOR 12V BATTERY

    MDR report key: 3050833 · Received April 10, 2013

    Report

    Report Number
    8030965-2013-01569
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    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. PLACEHOLDER .

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS DURING AN ORTHOPEDIC PROCEDURE ON (B)64 )2013, THE CASING FOR 12V BATTERY DID NOT MAKE A CONNECTION TO THE BATTERY. A BACK-UP DEVICE WAS USED RESULTING IN NO DELAY IN SURGERY. PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM, NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149874 SMALL BATTERY DRIVE CASING FOR 12V BATTERY HWE SYNTHES GMBH 008512

    Patients

    Seq Age Sex Outcome Treatment
    1