BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3070592 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10918
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    September 16, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ITEM WAS RECEIVED INOPERABLE. THE CUSTOMER REPORTS THE DEVICE WORKS INTERMITTENTLY. AFTER EVALUATING THE SMALL BATTERY DRIVE THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM IS NOT REPAIRABLE. A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON 04/05/2011 DUE TO ELECTRONIC CONTROL DAMAGE FOLLOWED BY A RETURN ON 10/13/2011 FOR MOTOR FAILURE. THERE ARE POSSIBLE RELEVANT ISSUES IDENTIFIED IN THE SERVICE HISTORY REVIEW HOWEVER NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. MANUFACTURING EVALUATION REPORTS THE PART WAS RECEIVED WITHOUT VISIBLE DAMAGES AND WITHOUT IMMEDIATE SIGNS OF ABUSE OR MISHANDLING. ALTHOUGH THE CUSTOMER COMPLAINT WAS VERIFIED, IT IS IMPOSSIBLE TO DETERMINE HOW THE PRODUCT WAS HANDLED DURING USE OR STERILIZATION PROCEDURES. THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL BATTERY DRIVE BEGAN TO WORK INTERMITTENTLY. THE INSTRUMENT WOULD WORK AND THEN STOP. DIFFERENT BATTERIES WERE USED AND THE DEVICE PERFORMED INTERMITTENTLY.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171971 SMALL BATTERY DRIVE HWE SYNTHES GMBH 001599

    Patients

    Seq Age Sex Outcome Treatment
    1