BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5 X 6 MM HIGH TORQUE SELF-DRILLING CROSS-DRIVE SCREW EACH

    MDR report key: 6043819 · Received October 20, 2016

    Report

    Report Number
    0001032347-2016-00594
    Event Type
    Injury
    Date Received
    October 20, 2016
    Report Date
    September 22, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    ON MAR 24, 2017, POTENTIAL LOTS WERE PROVIDED FOR THIS ITEM NUMBER AND THEIR RESPECTIVE DEVICE HISTORY RECORDS WERE REVIEWED; NO NON-CONFORMANCES WERE FOUND. POTENTIAL LOTS ARE BELOW: 735860, 522540, 932280, 508620, 544820, 905280, 905260, 898080, 435460, 435500, 300800, 435440, 777590, 416500, 286120, 498520, 069270, 095770, 104150, 099090.

    Additional Manufacturer Narrative · 1

    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. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. 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.

    Description of Event or Problem · 1

    (IN ADDITION TO WHAT WAS ALREADY REPORTED). ADDITIONAL INFORMATION WAS RECEIVED. IT IS REPORTED THAT THE SURGEON REPLACED THE SCREWS WITH 5 MM SCREWS. IT IS REPORTED THAT AS THE BROKEN SCREWS WERE NOT ABLE TO GET OUT OF THE PATIENT, THE SURGEON HAD TO USE A NEW HOLE. IT IS REPORTED THAT THE PATIENT IS "FINE SO FAR."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIOTOMY, THE SCREWS BROKE WHEN SCREWED INTO CRANIAL BONES. IT IS REPORTED THAT THE BREAKING DID NOT OCCUR UNTIL THE FINAL TIGHTENING "WHEN THE SCREW STILL PROTRUDES ABOUT 1/3 FROM THE BONE." IT IS REPORTED THAT THE PATIENT RETAINED A FOREIGN BODY. IT IS REPORTED THAT "IT IS UNCLEAR WHETHER BOLT PARTS WERE LIFTED." IT IS REPORTED THAT THERE WAS NO DELAY OVER THIRTY MINUTES. IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A WIDER SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694899 1.5 X 6 MM HIGH TORQUE SELF-DRILLING CROSS-DRIVE SCREW EACH BONE SCREW JEY BIOMET MICROFIXATION N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R