BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFIED SUTURE PUNCH, 4MM STRAIGHT

    MDR report key: 230649 · Received July 2, 1999

    Report

    Report Number
    1017294-1999-00024
    Event Type
    Malfunction
    Date Received
    July 2, 1999
    Date of Event
    June 7, 1999
    Report Date
    June 7, 1999
    Manufacturer
    LINVATEC CORP.
    Product Code
    LRY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PASSING SUTURE DURING AN ARTHROSCOPIC SHOULDER SURGERY, THE TIP OF THE DEVICE BROKE OFF INTO THE PATIENT'S SHOULDER. THE STAFF AT THE FACILITY DOES NOT BELIEVE THE TIP WAS RETRIEVED. UPON REMOVAL OF THE DEVICE THE "TOOTH" WAS MISSING. NO X-RAY WAS TAKEN. THE SURGEON IRRIGATED THE AREA AND DID A STANDARD CLOSURE. NO INJURY REPORTED OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODIFIED SUTURE PUNCH, 4MM STRAIGHT SUTURE PUNCH LRY LINVATEC CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other