BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRELOADED 2.8MM TI SUTURE ANCHOR W/ # 2 SUTURE

    MDR report key: 338927 · Received June 20, 2001

    Report

    Report Number
    1219602-2001-00045
    Event Type
    Malfunction
    Date Received
    June 20, 2001
    Date of Event
    March 22, 2001
    Report Date
    June 20, 2001
    Manufacturer
    SMITH & NEPHEW, INC. ENDOSCOPY DIVIS
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMITH AND NEPHEW INC. ENDOSCOPY DIVISION WAS NOTIFIED OF A 2.8MM SOFT TISSUE SUTURE ANCHOR WHICH BROKE DURING INSERTION. PROCEDURE PERFORMED WAS A ORBICULARIS OCULI REPAIR. RETRIEVAL OF THE BROKEN PIECE WAS NOT SUCCESSFUL AND LEFT EMBEDDED IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28045 PRELOADED 2.8MM TI SUTURE ANCHOR W/ # 2 SUTURE 2.8MM SOFT TISSUE SUTURE ANCHOR, PRELOAD MBI SMITH & NEPHEW, INC. ENDOSCOPY DIVIS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN