BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3640037 · Received February 21, 2014

    Report

    Report Number
    8030965-2014-00052
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Report Date
    January 23, 2014
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE IS A POWER DEVICE AND NOT FOR IMPLANT/EXPLANT USAGE. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL EVALUATION WAS COMPLETED. THE POWER TOOL EVALUATION INDICATED THE PART CONDITION WAS RECEIVED AS NORMAL WEAR. THE REPORT CONCLUDED: THE CUSTOMER DID NOT ALLEGE OR IDENTIFY ANY SPECIFIC DEFICIENCY; IT WAS OBSERVED DURING ROUTINE SERVICE AND OF THE SMALL BATTERY DRIVE THAT IT HAS AN UNUSUAL NOISE, VIBRATION, AND WORN COUPLING HEAD. EVIDENCE SUGGESTS THIS IS DUE TO USAGE WEAR OVER TIME. INVESTIGATION IS ONGOING, NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2014 BY THE ENGINEER TECHNICIAN THAT DURING THE MANUFACTURING EVALUATION ON THE SMALL BATTERY DRIVE (DEVICE: PART 532.010; LOT 003407) FOR COMPLAINT #(B)(4), IT WAS NOTED THE DEVICE HAD AN UNUSUAL NOISE, A VIBRATION, AND A WORN HEAD. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT EVENT IS FOR ONE POWERED DEVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109837 SMALL BATTERY DRIVE HWE SYNTHES GMBH 003407

    Patients

    Seq Age Sex Outcome Treatment
    1