BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFIX SCREW, TI, CANN., PT, 2.0 X 16MM

    MDR report key: 2850015 · Received November 29, 2012

    Report

    Report Number
    1220246-2012-00239
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K103705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT PART REMAINS IN THE PATIENT AND CANNOT BE RETURNED AND THE REMAINING PART WAS DISCARDED BY THE FACILITY, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDES BENDING OR LEVERAGING THE DEVICE PREMATURELY IN THE INSERTION PROCESS AND/OR IMPROPER BONE PREPARATION. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. PART REMAINS IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CLAVICLE PLATING, A GUIDE WIRE WAS USED AS TEMPORARY FIXATION. TRIPLE PLAY DEVICE WAS USED TO DRILL NEAR CORTEX AND THE SCREW WAS INSERTED ALMOST COMPLETELY. A SMALL PIECE BROKE OFF. THE FRAGMENT WAS LEFT IN REDUCTION AND THE PHYSICIAN FELT THE SCREW WAS SEATED AND SECURED ENOUGH FOR STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKFIX SCREW, TI, CANN., PT, 2.0 X 16MM SCREW, FIXATION, BONE HWC ARTHREX, INC. 95241149

    Patients

    Seq Age Sex Outcome Treatment
    1 Other