BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR BIO-COMP SWIVELOCK C 4.75X19.1MM

    MDR report key: 3812962 · Received May 15, 2014

    Report

    Report Number
    1220246-2014-00076
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 17, 2014
    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

    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 RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. AN INVALID LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. EVALUATION OF THE RETURNED IMPLANT REVEALED THE SWIVELOCK SCREW TO BE BROKEN IN HALF APPROXIMATELY AT ITS MIDPOINT. A SMALL SECTION OF THE DISTAL RIM (EDGE) IS MISSING FROM THE IMPLANT. ON BOTH HALVES OF THE ANCHOR THERE IS NO OBVIOUS DEFORMATION OR FLATTENING OF THE THREADS AND THE PARTING LINE CLEARLY VISIBLE ON THE THREADS CRESTS. PEEK EYELET WAS RETURNED UNDAMAGED. WHILE THE EVENT DESCRIPTION DESCRIBES THE ANCHOR AS BREAKING 4 WEEKS POST-OP THEN BEING REMOVED, THE DEVICE IS INCONSISTENT WITH ONE THAT HAS UNDERGONE INSERTION, IN-VIVO TIME, THEN REMOVAL. WITHOUT ADDITIONAL INFORMATION REGARDING THE CASE, A CAUSE IS UNKNOWN. HOWEVER, BASED ON DEVICE EVALUATION THE LIKELY CAUSE OF THE COMPLAINANT'S EVENT WAS THAT THE IMPLANT BROKE ON INSERTION WHICH COULD HAVE BEEN CAUSED BY NOT INSERTING THE IMPLANT CO-AXIAL TO THE BONE TUNNEL OR PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANCHOR BROKE 4 WEEKS POST-OP. IST SURGERY WAS ON (B)(6) 2014. ANOTHER ARTHROSCOPY WAS PERFORMED ON (B)(6) 2014 TO REMOVE THE BROKEN ANCHOR AND THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER MANUFACTURER'S ANCHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290771 SUTURE ANCHOR BIO-COMP SWIVELOCK C 4.75X19.1MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. INVALID

    Patients

    Seq Age Sex Outcome Treatment
    1 68 Other