BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWDRIVER HEX BALL END 3.5MM

    MDR report key: 4180599 · Received October 17, 2014

    Report

    Report Number
    0001825034-2014-08141
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 24, 2014
    Report Date
    March 16, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH AND TO REPORT DEVICE EVALUATION RESULTS. PRODUCT WAS RETURNED FOR EVALUATION ON NOVEMBER 25, 2014. BASED ON DEVICE HISTORY RECORDS REVIEW, THE PRODUCT WAS MADE TO PRINT AND CORRECT MATERIALS. PRODUCT LEFT CONFORMING TO PRINT AS THERE WAS NO EVIDENCE THAT STATES OTHERWISE. THIS HEX DRIVER IS DESIGNED WITH A LARGE HANDLE FOR EASY GRIP BY A SURGEON WEARING SLIPPERY GLOVES. THIS LARGE HANDLE ALSO MAKES IT POSSIBLE TO APPLY A TORQUE LARGE ENOUGH TO BREAK OFF THE TIP. BASED ON THE EVIDENCE, THE PRODUCT LIKELY FAILED DUE TO MISUSE, BY INSTRUMENT BEING PUT THROUGH TORSIONAL OVERLOAD, AND/OR NOT INSPECTED FOR WEAR AND DISFIGUREMENT WHICH MAY HAVE PREVENTED THE USE OF THE INSTRUMENT AND ITS FAILURE. THIS WAS NOT A SUPPLIER ISSUE.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY RELATED TO THE EVENT.THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER CARE AND HANDLING OF INSTRUMENTS IT STATES, "SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL KNEE REVISION PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, THE TIP OF THE SCREWDRIVER FRACTURED OFF IN THE SCREW. PATIENT RETAINED A FOREIGN BODY AS THE TIP OF THE SCREWDRIVER COULD NOT BE REMOVED. SURGEON CEMENTED THE FRACTURE TIP IN THE SCREW IN ORDER TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663070 SCREWDRIVER HEX BALL END 3.5MM SCREWDRIVER HXX BIOMET ORTHOPEDICS N/A 792690

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention