BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR BATTERY POWERED DRIVER

    MDR report key: 3133578 · Received May 29, 2013

    Report

    Report Number
    1719045-2013-01483
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 6/20/2013. THE EVALUATION SECTION OF INSPECTION SHEET 530FI405 REV ¿K¿ INDICATES THAT THE MOTOR WAS NOT FUNCTIONING. THE CIRCUIT BOARD, MOTOR/GEARHEAD, MEMBRANE SWITCH, FLEX CIRCUIT, AND ALL APPLICABLE PARTS WERE REPLACED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. ACCORDING TO THE ADDITIONAL EVALUATION (SERVICE HISTORY REVIEW) 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. PRODUCT CODE CORRECTED. ADDITIONAL PRODUCT CODE GXL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES CONSULTANT THAT A HAND PIECE FOR BATTERY POWERED DRIVER WAS A DAMAGED COMPONENT AND INOPERABLE ON AN UNKNOWN DATE. IT WAS ALSO REPORTED THAT THE DEVICE DID NOT MALFUNCTION DURING SURGERY WHILE BEING USED ON A PATIENT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235697 HAND PIECE FOR BATTERY POWERED DRIVER HXX SYNTHES MONUMENT 004615

    Patients

    Seq Age Sex Outcome Treatment
    1