BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5 X 4 MM HIGH TORQUE SELF-DRILL X-DRILL SCREW 5-PACK

    MDR report key: 5772123 · Received July 6, 2016

    Report

    Report Number
    0001032347-2016-00319
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    April 8, 2016
    Report Date
    June 13, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK121589
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. REPORT ONE OF TWO FOR THE SAME EVENT, REFERENCE 1032347-2016-00320-1.

    Additional Manufacturer Narrative · 1

    UDI #: (B)(4). REVIEW OF THE DEVICE HISTORY RECORDS SHOW THAT THE LOT WAS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. REPORT 2 OF 2 IS REPORTED ON MFR #0001032347-2016-00320.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE PRODUCT EVALUATION, FIELDS WERE UPDATED. . THE PRODUCTS WERE RETURNED FOR EVALUATION. ACCORDING TO THE EVALUATION, THE PRODUCT IDENTITIES WERE CONFIRMED. THE SCREWS (ITEMS OF THIS REPORT) AND PLATE (ITEM OF REPORT #0001032347-2016-00320-3) WERE VISUALLY EVALUATED WITH A DIGITAL MICROSCOPE. IN THE EVALUATION, ONE OF THE SCREWS WAS FOUND TO BE LOOSE AND ONE WAS FOUND TO BE STUCK IN THE PLATE. THE ONE STUCK IN THE PLATE HAS THE SCREW HEAD WEDGED INTO THE PLATE THROUGH HOLE. ACCORDING TO THE EVALUATION, THIS LIKELY OCCURRED FROM PUTTING THE SCREW IN AT A SIGNIFICANT ANGLE AND DRIVING THE SCREW IN WITH EXCESSIVE FORCE. BOTH SCREWS SHOW NO SIGNIFICANT DAMAGE TO THE THREADS. ACCORDING TO THE EVALUATION, BOTH SCREWS SHOW USE INDICATED BY DEFORMATION OF THE SLOTS. THE DEFORMATION IS SIGNIFICANT AND INDICATES EXCESSIVE FORCE OR MIS-ALIGNMENT WITH THE BLADE WHEN INSERTING. THE LOOSE SCREW WAS FUNCTIONALLY TESTED BY INSERTING IT INTO WHITE OAK. DESPITE THE SLOTS HAVING SIGNIFICANT DEFORMATION, THE SCREW WAS ABLE TO BE SUCCESSFULLY INSERTED. THE COMPLAINT WAS CONFIRMED AS THE SCREW HEADS WERE STRIPPED. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS EXCESSIVE FORCE. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. IN THE EVALUATION, THE PLATE WAS FOUND TO BE BENT, LIKELY TO THE PATIENTS ANATOMY AS INTENDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. REPORT 2 OF 2 IS REPORTED ON MFR #0001032347-2016-00320-3.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE EXCISION OF A TUMOR THE PLATE SHAPE "CHANGED" AND THE HEADS OF THE SCREWS BROKE. IT IS REPORTED THAT NO DELAY OCCURRED THAT EXCEEDED 30 MINUTES AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425828 1.5 X 4 MM HIGH TORQUE SELF-DRILL X-DRILL SCREW 5-PACK BONE SCREW JEY BIOMET MICROFIXATION N/A 259880

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention