BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3111251 · Received May 14, 2013

    Report

    Report Number
    8030965-2013-02189
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 16, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. INVESTIGATION COORDINATED BY (B)(4). REPORT RECEIVED INDICATES THE CUSTOMERS COMPLAINT THAT THIS DEVICE OPERATES INTERMITTENTLY DURING USE WAS CONFIRMED. THIS IS DUE TO USAGE AND WEAR OVER TIME.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS DURING A SURGICAL PROCEDURE ON (B)(6) 2013, THE SMALL BATTERY DRIVE WAS WORKING INTERMITTENTLY. IT WAS REPORTED THE PROCEDURE WAS NOT DELAYED AND A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM. NO HARM TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212019 SMALL BATTERY DRIVE HWE SYNTHES GMBH 2881

    Patients

    Seq Age Sex Outcome Treatment
    1