BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFIX SCREW, 2 X 13 MM

    MDR report key: 3894031 · Received June 25, 2014

    Report

    Report Number
    1220246-2014-00105
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 6, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    PMA / PMN Number
    K052614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. COMPLAINT CONFIRMED. THE EVALUATION REVEALED THAT ONE 2.0 MM QUICKFIX SCREW FROM AN AR-8690DS, CPR MINI-IMPLANT SYSTEM, WAS RETURNED. THE RETURNED SCREW'S DISTAL TIP IS BROKEN-OFF AND THE SCREW IS DETACHED FROM IT'S PROXIMAL DRIVE SECTION AT THE DRIVE/SCREW-HEAD INTERFACE. THE BROKEN DISTAL TIP WAS MOST LIKELY CAUSED BY NOT INSERTING THE IMPLANT CO-AXIAL TO THE PILOT HOLE, PRYING/LEVERAGING, IMPROPER BONE PREP AND OR COMING INTO CONTACT WITH ANOTHER METAL OBJECT OR HARD BONE DURING INSERTION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION, THE DISTAL TIP OF THE IMPLANT BROKE OFF INTO THE PATIENT'S BONE. THE SURGEON DID NOT ATTEMPT TO REMOVE THE FRAGMENT BECAUSE OF ITS DEEP SEATED DEPTH WITHIN THE BONE. THE CASE WAS COMPLETED SUCCESSFULLY WITH THE USE OF TWO ADDITIONAL IMPLANTS. THE PROCEDURE WAS A PLANTAR PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371898 QUICKFIX SCREW, 2 X 13 MM PLATE, FIXATION, BONE HRS ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other