BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRELOADED RC5 5.0MM TI SUTURE ANCHOR

    MDR report key: 337837 · Received June 15, 2001

    Report

    Report Number
    1219602-2001-00046
    Event Type
    Malfunction
    Date Received
    June 15, 2001
    Date of Event
    May 17, 2001
    Report Date
    June 14, 2001
    Manufacturer
    SMITH & NEPHEW, INC. ENDOSCOPY DIVIS
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMITH & NEPHEW, INC., ENDOSCOPY DIVISION WAS NOTIFIED OF A 5.0MM SOFT TISSUE SUTURE ANCHOR WHICH BROKE DURING INSERTION IN A ROTATOR CUFF REPAIR. THE BROKEN ANCHOR WAS REMOVED FROM THE PT CAUSING AN APPROXIMATE 20 MINUTE DELAY. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27570 PRELOADED RC5 5.0MM TI SUTURE ANCHOR 5.0MM SOFT TISSUE SUTURE ANCHOR MBI SMITH & NEPHEW, INC. ENDOSCOPY DIVIS NA Q1501E.1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN