BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCH BIOCOMP SWI- VELOCK SP 5.5 X 24.5MM

    MDR report key: 3193126 · Received June 27, 2013

    Report

    Report Number
    1220246-2013-00115
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K101823
    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 NOT PROVIDED, SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. ACCORDING TO THE EVENT DESCRIPTION, THE SWIVELOCK IMPLANT WAS FOUND IN THE SUBACROMIAL AREA AS A FREE BODY, WHILE THE TITANIUM TIP WAS STILL FIXED IN THE HUMERUS. AT THIS TIME, THE ACTUAL CAUSE OF THE EVENT CANNOT BE DETERMINED AND THE MOST LIKELY CAUSE OF THE EVENT WAS PATIENT POST-OP NON-COMPLIANCE OR MIGRATION OF THE IMPLANT OUT OF SOFT BONE. THE SURGEON IS RESPONSIBLE FOR THE PROPER SELECTION OF DEVICES TO BE USED BASED ON PATIENT BONE QUALITY. 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. DEVICE WAS DISCARDED BY THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 14 DAYS POST-OP, AFTER ROTATOR CUFF REPAIR, A FAILURE OF THE SPEEDFIX-FIXATION WAS DISCOVERED. THE SWIVELOCK IMPLANT WAS FOUND IN THE SUBACROMIAL AREA AS A FREE BODY, WHILE THE TITANIUM ANCHOR STILL WAS FIXED IN THE HUMERUS. IN A REVISION SURGERY, THE FREE BODY WAS REMOVED AND REFIXATION WITH A FIBERTAPE AND SWIVELOCK WERE PERFORMED. DURING REVISION, THE SURGEON FOUND EVIDENCE OF SYNOVIALITIS (RHEUMATISM) IN THE SUBACROMIAL AREA. NO CARTILAGE DAMAGE WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292988 SUTURE ANCH BIOCOMP SWI- VELOCK SP 5.5 X 24.5MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other