BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW 8 X 28MM, ROUND DELTA, BIOCOMPOSITE

    MDR report key: 2132253 · Received June 17, 2011

    Report

    Report Number
    1220246-2011-00101
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    April 4, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K071176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. EVALUATION OF THE RETURNED IMPLANT CONFIRMS THE COMPLAINT. THE LARGEST PIECE OF RETURNED IMPLANT MEASURES APPROXIMATELY .686" OR 62% OF THE OAL AND IS FROM THE PROXIMAL END OF THE SCREW. FOUR SMALLER PIECES OF THREAD MATERIAL WERE ALSO RETURNED. COMPLAINANT'S EVENT IS TYPICALLY CAUSED BY NOT INSERTING THE IMPLANT CO-AXIAL TO THE BONE TUNNEL, PRYING OR LEVERAGING, IMPROPER BONE PREPARATION OR FLEXING THE JOINT DURING INSERTION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED FROM THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, 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. COMPLAINANT'S EVENT TYPICALLY CAUSED BY NOT INSERTING THE IMPLANT CO-AXIAL TO THE BONE TUNNEL, PRYING/LEVERAGING THE IMPLANT OR IMPROPER BONE PREPARATION. PER CUSTOMER, NOT RETURNING DEVICE.

    Description of Event or Problem · 1

    THE IMPLANT BROKE AT THE TIP AND HEAD UPON INSERTION INTO THE FEMUR. CONSEQUENCES: INSECURE ATTACHMENT, NON-OPTIMAL POSITION. SURGERY WAS COMPLETED WITH THIS SCREW, SCREW FRAGMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW 8 X 28MM, ROUND DELTA, BIOCOMPOSITE FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 358138

    Patients

    Seq Age Sex Outcome Treatment
    1 Other