BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-TRANSFIX SCREW, 5MM X 50 MM

    MDR report key: 1834390 · Received September 15, 2010

    Report

    Report Number
    1220246-2010-00179
    Event Type
    Injury
    Date Received
    September 15, 2010
    Date of Event
    January 8, 2008
    Report Date
    September 1, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K062466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    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 IMPLANT WAS IN PLACE FOR ABOUT 16 MONTHS. ABSORPTION OF BIODEGRADABLE IMPLANTS BEGINS AT IMPLANTATION AS A RESULT OF NORMAL HYDROLYSIS OF THE IMPLANT. BIOABSORBABLE IMPLANTS ARE DESIGNED WITH MATERIAL PROPERTIES REQUIRED TO MAINTAIN NECESSARY PROPERTIES THROUGHOUT THE HEALING PROCESS UNDER NORMAL PATIENT CONDITIONS. THE ROOT CAUSE FOR THIS EVENT IS UNDETERMINED BUT THE MOST LIKELY CAUSE IS THAT THE IMPLANT MAY HAVE CRACKED OR BROKEN WHEN IT WAS INITIALLY INSERTED AND MAY HAVE GONE UNNOTICED BY THE SURGEON. 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

    POST-OP FAILURE. IT WAS REPORTED THAT THE PATIENT HAD PAIN IN THE RIGHT KNEE. THE TIP OF THE BIO- TRANSFIX WAS FOUND TO BE FLOATING IN THE KNEE. REVISION SURGERY NEEDED.NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED AT THE TIME THIS EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-TRANSFIX SCREW, 5MM X 50 MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE. MAI ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other