BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCH BIOCOMP CORK CREW FT VENTD 5.5X14.7MM

    MDR report key: 2882091 · Received December 20, 2012

    Report

    Report Number
    1220246-2012-00260
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    May 10, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K082810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP IS TO ADD LOT NUMBERS FOR ALL THE DEVICES WHICH WERE PREVIOUSLY UNKNOWN AND ALSO TO CORRECT ONE OF THE THREE DEVICES TO A DIFFERENT PART NUMBER (CATALOG #). DISCARDED BY FACILITY.

    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. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS AN ADVERSE REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED. PRODUCT DIRECTIONS FOR USE WARNS OF ADVERSE EFFECTS LIKE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS AS WELL AS INFECTIONS BOTH DEEP AND SUPERFICIAL TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO DEVICE MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. 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 DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POSSIBLE REACTION. ROTATOR CUFF REPAIR AND SUBSCAP PROCEDURES WERE PERFORMED ON (B)(6) 2011. POST-OP, PATIENT COMPLAINED OF A PAINFUL RANGE OF MOTION. DURING A FOLLOW UP VISIT, A CULTURE WAS TAKEN AND DID NOT SHOW AN INFECTION. PASSPORT CANNULAS, 7 X 7 TWIST IN CANNULA AND A CRYSTAL CANNULA WERE USED. A REUSABLE PUNCH FOR 5.5 CORKSCREWS WAS USED AND NO TAPS. REVISION/REMOVAL OF ANCHORS DONE ON (B)(6) 2012. NO NEW IMPLANTS WERE INSERTED AT THIS POINT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE ANCH BIOCOMP CORK CREW FT VENTD 5.5X14.7MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 434511

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other AR-2323BCC- SUTURE ANCHOR, BIO-COMP, LOT # UNKNOWN| AR-2324BCCT, LOT 432594| AAR-1922BCM, LOT #432224| AR-1922BCM, BIO-COMPOSITE PUSHLOCK- LOT # UNKNOWN.