BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETAC INSTRUMENTS

    MDR report key: 147715 · Received February 3, 1998

    Report

    Report Number
    147715
    Event Type
    Injury
    Date Received
    February 3, 1998
    Date of Event
    December 10, 1997
    Report Date
    December 23, 1997
    Manufacturer
    ACUFEX MICROSURGICAL INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD ORTHOSCOPIC PROCEDURE. INSTRUMENT USED FOR PLACEMENT OF SURETAC SUTURE. INSTRUMENT TIP BROKE OFF IN PT'S SHOULDER. SURGEON HAD TO OPEN SHOULDER TO RETRIEVE BROKEN PIECE AND REPAIR SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURETAC INSTRUMENTS GLENOID RETRACTOR HRX ACUFEX MICROSURGICAL INC. 013447 L1-96 *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention