BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY REAMER/DRILL

    MDR report key: 3060894 · Received April 16, 2013

    Report

    Report Number
    8030965-2013-10734
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    July 10, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. MANUFACTURING EVALUATION, VISUAL INSPECTION REPORT OF THE RETURNED DEVICE STATED NO VISIBLE DAMAGES, MACHINE IS NOT WORKING. OUR INSPECTION HAS SHOWN THAT A LOT OF LIQUID WAS IN THE HOUSING. THEREFORE THE MOTOR WAS DEFECTIVE AND THE MACHINE DID NOT FUNCTION ANYMORE. THE AMOUNT OF LIQUID WITHIN THE HOUSING IS A CLEAR INDICATION THAT THIS MACHINE WAS SUBMERGED IN LIQUID, WHICH IS NOT ACCORDING TO OUR GUIDELINE. THIS IS AN INDICATION THAT INCORRECT REPROCESSING CAUSED THE DAMAGE OF THE MACHINE. THIS COMPLAINT HAS BEEN DEEMED INVALID FROM A MANUFACTURING STANDPOINT.

    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. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN SETTING UP FOR A PROCEDURE, THE SPD NOTICED THAT WHEN THEY ATTACHED THE BATTERY PACK TO THE DRILL, IT WOULD NOT ACTIVATE AND WOULD NOT FUNCTION PROPERLY. THE SURGEON USED A DIFFERENT BATTERY REAMER FOR THE PROCEDURE, WITH NO FURTHER PROBLEMS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162726 BATTERY REAMER/DRILL MOQ SYNTHES GMBH 4247

    Patients

    Seq Age Sex Outcome Treatment
    1