BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM BIOCOMPOSITE CORKSCREW FT

    MDR report key: 2072462 · Received April 29, 2011

    Report

    Report Number
    1220246-2011-00075
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    February 3, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K082810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE INSUFFICIENT BONE PREPARATION FOR THE HARDNESS OF BONE ENCOUNTERED, NOT INSERTING THE IMPLANT CO-AXIAL TO THE BONE TUNNEL, PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED, AND/OR OVER-INSERTION. 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. PART REMAINS IN PATIENT.

    Description of Event or Problem · 1

    PROCEDURE: ROTATOR CUFF REPAIR. AFTER HOLE PREPARATION,THE SCREW BROKE AT THE MIDDLE OF INSERTION. THE HALF SCREW REMAINED IN THE BONE. SURGEON HAD TO ENLARGE THE INCISION TO RETRIEVE THE BROKEN SCREW. NO 2ND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM BIOCOMPOSITE CORKSCREW FT FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 399951

    Patients

    Seq Age Sex Outcome Treatment
    1 Other