BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-COMP INTERF SCREW CANN DELTA TAP 11 X 35MM

    MDR report key: 4122454 · Received September 26, 2014

    Report

    Report Number
    1220246-2014-00174
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 8, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K071176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT IS DAMAGE AND/OR UNDER OR OVER INSERTION OF THE IMPLANT AT THE TIME OF IMPLANTING WHICH LED TO THE BREAKAGE AND POST-OP FRAGMENT IN THE JOINT SPACE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE 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

    IT WAS REPORTED BY THE PATIENT THAT THE ORIGINAL ACL SURGERY WAS IN (B)(6) 2013. PATIENT HAD PAIN FOR 10 MONTHS. AN MRI FOUND A TORN MENISCUS WHICH WAS FIXED. PATIENT STILL HAD PAIN. SURGEON WENT IN ON (B)(6) 2014 AND FOUND THE ANCHOR BROKEN IN PIECES AND HOLE IN THE BONE. ANCHOR WAS REMOVED AND SHE NEEDED A BONE GRAFT. SURGEON WAS THE SAME FOR BOTH CASES. FOLLOW-UP: ORIGINAL SURGERY FOR AN ACL RECONSTRUCTION, (B)(6) 2013. THE SCREW INSERTED WAS A 11MM X 35 MM BIO-TENODESIS PLACED IN THE TIBIAL TUNNEL. IN (B)(6) 2014 THE PATIENT BEGAN TO HAVE KNEE PAIN. AFTER AN EXAM AND X-RAY, THE SURGEON SCHEDULED A SECOND SURGERY FOR (B)(6) 2014. AS THE SURGEON RE-OPENED THE INCISION SITE, A PASTY SUBSTANCE WITH SMALL PIECES OF THE IMPLANT WAS FOUND WITHIN THE TIBIAL TUNNEL. THE MENISCUS AREA WAS DEBRIDED AND THE TUNNEL CLEANED, A BONE PLUG WAS USED TO CLOSE THE TUNNEL. NO NEW IMPLANTS WERE INSERTED THE GRAFT HAD HELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600762 BIO-COMP INTERF SCREW CANN DELTA TAP 11 X 35MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 506173

    Patients

    Seq Age Sex Outcome Treatment
    1 Other