BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, CANN. DELTA TAPERED BIO-INT. 10MM

    MDR report key: 2061775 · Received April 19, 2011

    Report

    Report Number
    1220246-2011-00070
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    December 22, 2010
    Report Date
    April 12, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K071176
    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. LOT NUMBER WAS REQUESTED BUT NOT PROVIDED, THEREFORE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT IS DAMAGE TO THE IMPLANT AT THE TIME OF INSERTION WHICH LED TO THE BREAKAGE AND POST-OP FRAGMENT IN THE JOINT SPACE. 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. UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    THE SCREW POSSIBLY BROKE DURING AN OPERATION IN THE RIGHT KNEE. THE TIP OF THE SCREW HAD MIGRATED INTO THE KNEE JOINT AND HAD CAUSED A CARTILAGE INJURY. THIS WAS DISCOVERED DURING A REVISION SURGERY AND THE BROKEN SCREW WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW, CANN. DELTA TAPERED BIO-INT. 10MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other