BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTHREX, INC.

    MDR report key: 399654 · Received June 12, 2002

    Report

    Report Number
    1220287-2002-00001
    Event Type
    Other
    Date Received
    June 12, 2002
    Date of Event
    April 24, 2002
    Report Date
    June 12, 2002
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT ORTHOPEDIC REPAIR OF ROTATOR CUFF INJURY IN 2001 USING THREE (3) BIO-ABSORBABLE CORKSCREW ANCHORS. AT 6 WEEKS POST-SURGERY PATIENT PRESENTED WITH RECURRENT FAILURE OF ROTATOR CUFF. MRI REVEALED RECURRENT TEAR OF SUPRASPINATUS TENDON WITH MUSCULOTENDINOUS JUNCTION RETRACTION AND SUPASPINATUS MUSCLE ATROPHY. APPROXIMATELY 6 MONTHS LATER, RECURRENT ROTATOR CUFF TEAR REPAIR UNDERTAKEN IN 2002. DURING SURGICAL PROCEDURE, ONE OF CORKSCREWS FOUND BENT BUT STILL SECURED IN BONE. MUSCLE HAD PULLED AWAY FROM HEAD OF CORKSCREW. ALSO DISCOVERED A TROUGH WHERE ONE OF THE CORKSCREWS HAD BROKEN OFF. THE TEAR WAS REPAIRED USING THREE #1 TYCRONS SUTURES TO ATTACH A FULL THICKNESS LAYER OF ROTATOR CUFF TO THE TROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX, INC. HEADED BIO-ABSORBABLE CORKSCREW MAI ARTHREX, INC. AR-1921B 24155

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other