BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 2971411 · Received February 21, 2013

    Report

    Report Number
    8030965-2013-00580
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    December 31, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE RECEIVED FOR EVALUATION, DATE UNKNOWN. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED OR DUPLICATED. THE UNIT WAS TESTED AND PASSED ALL OPERATIONAL SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. DATE OF EVENT IS REPORTED AS UNKNOWN DAY IN (B)(6) 2012.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PRIOR TO A PROCEDURE, ON AN UNKNOWN DAY IN (B)(6) 2012, A SMALL BATTERY DRIVE WOULD RUN CONTINUOUSLY WHEN THE BATTERY WAS INSERTED INTO THE DRILL. A DIFFERENT DRILL WAS USED FOR THE PROCEDURE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77039 SMALL BATTERY DRIVE SMALL BATTERY DRIVE HWE SYNTHES GMBH 001220

    Patients

    Seq Age Sex Outcome Treatment
    1