BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR, BIO-COMP SWIV SP, 5.5 X 24.5 MM V

    MDR report key: 2013192 · Received March 10, 2011

    Report

    Report Number
    1220246-2011-00035
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K101823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    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 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. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT; NO ISSUES WERE FOUND WITH THE STERILIZATION OF THIS LOT. THIS DEVICE IS SUPPLIED STERILE. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE POST-OPERATIVE INFECTION COULD NOT BE DETERMINED. THE MOST LIKELY CAUSE FOR THIS TYPE OF EVENT IS A NOSOCOMIAL SOURCE OR PATIENT NON-COMPLIANCE WITH POST-OP WOUND CARE DIRECTIONS. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. 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. DEVICE REMAINS IN PATIENT.

    Description of Event or Problem · 1

    INFECTION. ARTHROSCOPIC ROTATOR CUFF REPAIR, SUBACROMIAL DECOMPRESSION, DEBRIDEMENT PARTIAL BICEPS TENDON RUPTURE RIGHT SHOULDER. NO KNOWN DRUG ALLERGIES. SYMPTOMS: REDNESS, SWELLING, DRAINAGE 18 DAYS POST-OPERATIVELY, SUBSEQUENT INCISION AND DRAINAGE, AND CULTURING OF WOUND. SEEN BY INFECTIOUS DISEASE PHYSICIAN. CURRENT CONDITION INCISION CLEAN, DRY, INTACT, NO DRAINAGE OR ERYTHEMA. THE ORGANISM FOUND IN THE CULTURE WAS STAPHYLOCOCCUS CAPITUS AND RARE ANAEROBIC GRAM POSITIVE BACILLI CLOSELY RESEMBLING PROPIONIBACTERIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE ANCHOR, BIO-COMP SWIV SP, 5.5 X 24.5 MM V FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 328317

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other AR-1922BCM LOT 356216| AR-1927BCFT LOT 357628| AR-2324BCM LOT 356562