BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE SCREW, SS, 4.0 X 40MM, CANCELLOUS

    MDR report key: 2072475 · Received April 29, 2011

    Report

    Report Number
    1220246-2011-00067
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    PMA / PMN Number
    K052614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    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 WAS NOT RETURNED, 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 REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE LEVERAGING DURING INSERTION OR IMPROPER BONE PREPARATION AND/OR SELECTION OF THE INCORRECT SCREW SIZE AS WELL AS OVER-INSERTION OR INSERTING THE IMPLANT AT AN ANGLE NOT CO-AXIAL TO THE PILOT HOLE. THE DFU STATES TO USE THE APPROPRIATE ARTHREX DRILL TO PREPARE THE BONE AND MEASURE THE DEPTH OF THE HOLE TO DETERMINE THE APPROPRIATE SCREW LENGTH. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. OTHER: DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    THE SCREW HEAD BROKE OFF. THE HEAD WAS RETRIEVED. THE REMAINDER OF THE SCREW WAS LEFT IN THE PATIENT. RIGHT FIBULA FRACTURE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE SCREW, SS, 4.0 X 40MM, CANCELLOUS PLATE, FIXATION, BONE HRS ARTHREX, INC. 452254

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4) AND (B)(4)