BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED DRILL BIT, 4.0MM

    MDR report key: 3894034 · Received June 25, 2014

    Report

    Report Number
    1220246-2014-00107
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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. THE EVALUATION REVEALED THAT THE RETURNED DRILL BIT'S DISTAL TIP IS BROKEN AND DAMAGED. THE MOST LIKELY CAUSE OF THE EVENT IS AS STATED IN THE COMPLAINANT'S DESCRIPTION THAT DURING PREPARATION FOR THE LAST SCREW, THE CANNULATED DRILL BIT MADE SLIGHT CONTACT WITH A PREVIOUSLY PLACED SCREW AND ON CONTACT WITH THAT SCREW, APPROX.1 CM OF THE DRILL BIT SHEARED OFF. 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 PLACEMENT OF THE LAST SCREW, THE CANNULATED DRILL BIT MADE A SLIGHT CONTACT WITH A PREVIOUSLY PLACED SCREW AND ON CONTACT WITH THAT SCREW, APPROXIMATELY 1CM OF THE DRILL BIT SHEARED OFF. SHEARED OFF PIECE WAS IMPOSSIBLE TO REMOVE. PROCEDURE WAS AN ARTHROSCOPIC ANKLE FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371899 CANNULATED DRILL BIT, 4.0MM BIT, DRILL HTW ARTHREX, INC. 041414

    Patients

    Seq Age Sex Outcome Treatment
    1 Other