BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Ø1.5MM DRILL BIT W/8MM STOP 15MM F/90° SCRWDRVR MTRXMANDBL

    MDR report key: 3008125 · Received March 18, 2013

    Report

    Report Number
    8030965-2013-10524
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    February 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZI
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES DZJ.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILATERAL MANDIBLE FRACTURE PROCEDURE, TWO DRILL BITS BROKE. BOTH SURGEONS CHOSE TO HAND DRILL RATHER THAN DRILL USING POWER. ONE SURGEON FELT THAT HE GETS A BETTER RESULT BY HAND DRILLING RATHER THAN POWER DRILLING. CONSULTANT DID ADVISE THE SURGEONS THAT THE DRILL IS MEANT TO BE USED WITH POWER. THE BROKEN DRILL BIT TIPS WERE RETRIEVED. SURGEONS THEN USED ANOTHER DRILL BIT TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS AND NO HARM TO PATIENT. BROKEN DRILL BITS WERE DISCARDED. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111513 Ø1.5MM DRILL BIT W/8MM STOP 15MM F/90° SCRWDRVR MTRXMANDBL DZI SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR