BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARB-BITE CRILE-WOOD NH 6

    MDR report key: 20112562 · Received August 30, 2024

    Report

    Report Number
    3014334038-2024-00182
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    July 22, 2024
    Report Date
    October 3, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    MDM
    UDI-DI
    10381780377115
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE FULL NAME OF THE REPORTING FACILITY IS (B)(6) CENTER FOR FACIAL PLASTIC SURGERY. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE CARB-BITE CRILE-WOOD NH 6 (121130) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH EFFORT (GFE) ATTEMPTS WERE MADE. LOT NUMBER HAS BEEN PROVIDED; DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A PROBABLE ROOT CAUSE IS THAT THE BREAKING MAY HAVE RESULTED FROM ROUGH HANDLING OR EXPOSURE TO NON NEUTRAL PH SOLUTION/CLEANERS, LEADING TO CORROSION. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE DRIVER/CARB-BITE CRILE-WOOD NEEDLEHOLDER 6 (121130) BROKE DURING A FACIAL PROCEDURE. THE TIP BROKE OFF COMPLETELY AND FELL INTO THE SURGICAL SITE. STAFF RETRIEVED THE BROKEN END WITH FORCEPS AND FLUSHED THE SITE. IT WAS REPORTED THAT THE DELAY WAS NOT SIGNIFICANT, LESS THAN 30 MINUTES; JUST LONG ENOUGH TO OPEN A BACK-UP INSTRUMENT. STAFF WAS ABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OCCURRED. THE CUSTOMER REPORTED THAT THE INSTRUMENT WAS NOT BEING WEIGHTED OR USED IN ANY ROUGH PROCEDURES AND HAVE BEEN IN USE FOR LESS THAN 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006015 CARB-BITE CRILE-WOOD NH 6 CARDIOVASCULAR NEEDLE HOLDERS MDM INTEGRA LIFESCIENCES MANSFIELD AB2303 10381780377115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown