BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM IMF SCREW SELF-DRILLING 12MM

    MDR report key: 3072217 · Received April 23, 2013

    Report

    Report Number
    2520274-2013-02069
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    DZL
    PMA / PMN Number
    K010527
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE RETURNED SCREW IS IN TWO PIECES. THE SCREW BROKE JUST BELOW THE HEAD AT THE 2ND THREAD REVOLUTION. THE HEAD PIECE OF THE SCREW IS IN GOOD CONDITION. THE THREADED END OF THE SCREW HAS EXTENSIVE DAMAGE. THE VERY TIP OF THE SCREW IS BROKEN OFF. HALF OF THE THREADS CLOSET TO THE TIP REMAINED INTACT. HOWEVER, THE OTHER HALF OF THE THREADS ARE SMASHED-PEELED. ALTHOUGH THERE IS DAMAGE AROUND THE FLUTES ALL FLUTES ARE VISIBLY PRESENT. VISUAL EXAMINATION IS CONSISTENT WITH PRODUCT COMPLAINT. THE THREAD PROFILE, THREAD MAJOR DIAMETER AND THREAD MINOR WERE CHECKED AT THE PORTION OF THREAD WITHOUT DAMAGE AND NO ISSUES WERE FOUND. HOWEVER THESE FEATURES COULD NOT BE CHECKED OVER THE ENTIRE THREAD LENGTH DUE TO DAMAGE. THE OVERALL LENGTH COULD NOT BE CHECKED SINCE THE SCREW WAS BROKEN INTO 2 PIECES AND THE TIP IS BROKEN OFF. SINCE THE TIP WAS BROKEN THE PROFILE COULD NOT BE CHECKED. THE MATERIAL WAS CHECKED WITH A NITON GUN AND PASSED SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING A BILATERAL MANDIBLE FRACTURE SURGERY ON (B)(6) 2013, THE FIRST 2.0MM IMF SCREW INSERTED BROKE. THE SURGEON DUG OUT THE PORTION THAT WAS STUCK IN THE BONE AND RETRIEVED IT (APPROXIMATELY A HALF INCH LONG) AND WAS ABLE TO REPLACE IT WITHOUT PROBLEMS. REPORTEDLY TWO PLATES AND A TOTAL OF TWELVE SCREWS WERE IMPLANTED. DURING THE SURGERY, REPORTEDLY ONE AND A HALF INCH OF THE 1.8MM DRILL BIT BROKE OFF AS IT WENT THROUGH THE TROCAR. PER THE SALES CONSULTANT, THE RESIDENT WAS PUSHING DOWN HARD AND HE COULD SEE THE DRILL BIT FLEXING. THE DRILL BIT WAS CHANGED, THE BROKEN FRAGMENT WAS RETRIEVED AND SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS. SURGERY WAS PROLONGED FOR APPROXIMATELY A HALF HOUR TO 40 MINUTES. NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175548 2.0MM IMF SCREW SELF-DRILLING 12MM DZL SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention