BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.65 X 5 MM HIGH TORQUE SELF-DRILL CROSS-DRIVE SCREW 5-PACK

    MDR report key: 6145135 · Received December 5, 2016

    Report

    Report Number
    0001032347-2016-00732
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 15, 2016
    Report Date
    November 15, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK121624
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN, HOWEVER POTENTIAL LOTS WERE IDENTIFIED. THE DEVICE HISTORY RECORDS FOR THE LOTS LISTED BELOW WERE REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED. PART #: 95-6105X, LOT #: 821960, MANUFACTURE DATE: 04/19/2016, UDI #: (B)(4); 95-6105X, 841420, 05/03/2016, (B)(4); 95-6105X, 372400, 06/10/2016, (B)(4); 95-6105X, 513610, 06/17/2016, (B)(4); 95-6105X, 018420, 10/25/2016, (B)(4); 95-6105X, 071170, 11/01/2016, (B)(4); 95-6105X, 954290, 10/24/2016, (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTITY WAS CONFIRMED IN THE EVALUATION. VISUAL INSPECTION REVEALED THE SCREWS ARE FRACTURED TRANSVERSELY APPROXIMATELY HALFWAY DOWN THE SHAFT OF THE SCREW; THEREFORE THE COMPLAINT IS CONFIRMED. THE GROOVES ON THE HEAD OF THE SCREW SHOW DAMAGE CONSISTENT WITH CONSIDERABLE TORQUE. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE SCREW. THE MOST-LIKELY CAUSE WAS DETERMINED TO BE EXCESSIVE TORQUE. THE CUSTOMER MOST-LIKELY APPLIED EXCESSIVE TORQUE TO THE SCREW DURING THE INSERTION ATTEMPT.

    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.

    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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SCREW HEADS BROKE OFF WHILE INSERTING INTO THE BONE. IT IS REPORTED THAT AFTER TWO SCREWS BROKE, THE SURGEON DECIDED TO DRILL HOLES IN THE BONE WITH A DRILL BEFORE INSERTING THE SCREWS. IT IS REPORTED THE TWO SCREW TIPS WERE LEFT IN THE SKULL BONE. IT IS REPORTED THERE WAS NOT A DELAY OVER THIRTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796013 1.65 X 5 MM HIGH TORQUE SELF-DRILL CROSS-DRIVE SCREW 5-PACK BONE SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability