BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM IMF SCREW SELF-DRILLING 12MM

    MDR report key: 2830993 · Received November 14, 2012

    Report

    Report Number
    2520274-2012-03139
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Product Code
    HWC
    PMA / PMN Number
    K010527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED. THE SCREW IS BROKEN MID SHAFT. BOTH PIECES OF THE SCREW WERE RETURNED FOR EVALUATION. THE TIP END OF THE SCREW AND THE THREADS AT THE BREAK POINT ARE DAMAGED. VISUAL EXAMINATION IS CONSISTENT WITH PRODUCT COMPLAINT. THE THREAD PROFILE, THREAD MAJOR DIAMETER AND THREAD MINOR DIAMETER WERE ALL CHECKED AND FOUND ACCEPTABLE. HOWEVER INSPECTION WAS LIMITED TO ONLY SECTIONS OF THREADS THAT WERE NOT DAMAGED. THE TIP PROFILE OF SCREW COULD NOT BE EXAMINED DUE TO DAMAGE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED ON (B)(4) 2012. PRODUCT DEVELOPMENT ENGINEER EVALUATED THE DEVICE AND INDICATED THE 12MM LENGTH 2.0MM SELF-DRILLING IMF SCREW (P/N 201.932) WAS RETURNED IN TWO PIECES. THE TIP OF THE SCREW IS BROKEN OFF ABOUT 3 THREADS FROM THE BOTTOM OF THE SCREW HEAD. THE FRACTURE SURFACE AND TWISTING IN THE LAST THREAD CREST SUGGEST THAT THE SCREW BROKE DUE TO TORSION. THE SCREW IS SEVERELY DEFORMED NEAR THE FRACTURE LOCATION. THIS IS LIKELY DUE TO THE SCREW BEING REMOVED. NO RADIOGRAPHS OR INFORMATION RELATING TO THE PATIENTS BONE DENSITY WERE PROVIDED FOR THIS COMPLAINT. INSERTING SCREWS INTO DENSE CORTICAL BONE OR COMING INTO A CONTACT WITH A TOOTH ROOT CAN RESULT IN INCREASED INSERTION TORQUE AND CAUSE SCREW FAILURE. FOR THIS REASON, THE IMF SCREW SET TECHNIQUE GUIDE SUGGESTS PRE-DRILLING DENSE CORTICAL BONE AND TAKING CARE TO AVOID THE TOOTH ROOTS. THE SCREW IS MADE OF EXTRA HARD 316L STAINLESS STEEL FOR ITS SUPERIOR STRENGTH PROPERTIES AS COMPARED TO TITANIUM OR OTHER GRADES OF STAINLESS STEEL, AND IT WAS DESIGNED TO EXCEED THE MAXIMUM EXPECTED INSERTION TORQUE BY A FACTOR OF 1.5. BASED ON THE AVAILABLE INFORMATION, THE FAILURE MECHANISM FOR THIS SCREW CANNOT BE DETERMINED WITH CERTAINTY. THE DESIGN RISK ASSESSMENT WAS REVIEWED AND FOUND TO BE ADEQUATE FOR THE INTENDED USE. THE RISK ANALYSIS DOES NOT NEED TO BE REVISED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING A PROCEDURE FOR A MANDIBLE FACIAL FRACTURE SURGEON WAS INSERTING IMF SCREW INTO MAXILLA AND THE SCREW BROKE IN HALF. SURGEON WAS ABLE TO BURR THE BROKEN SHAFT OUT AND REPLACED WITH DBX PUTTY. ALL PIECES WERE RETRIEVED. PROCEDURE PROLONGED BY APPROXIMATELY 30 MINUTES. SURGEON COMPLETED PROCEDURE WITH NO FURTHER PROBLEM, IT WAS NOTED, NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.0MM IMF SCREW SELF-DRILLING 12MM IMF SCREW SELF-DRILLING HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR