BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARB-BITE CRILE-WOOD NH 8

    MDR report key: 15175503 · Received August 5, 2022

    Report

    Report Number
    3014334038-2022-00175
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    June 30, 2022
    Report Date
    September 7, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    DWS
    UDI-DI
    10381780377139
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 NEEDLE HOODLER (121132) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THUS, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE ISSUE OF BREAKING MAY BE THE RESULT OF ROUGH HANDLING OR ENVIRONMENTAL DAMAGE. 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

    THE FOLLOWING INFORMATION WAS REPORTED VIA UF/IMPORTER REPORT# (B)(4), RECEIVED ON 14-JULY-2022: WHILE SURGEON WAS WORKING, NEEDLE DRIVER BROKE IN THE WOUND. ALL PIECES FOUND AND VISUALIZED. X-RAY CALLED AND 2 VIEWS TAKEN AND THERE WAS NO FOREIGN BODY IN WOUND. ORIGINAL INTENDED PROCEDURE: OPEN REDUCTION INTERNAL FIXATION RIGHT DISTAL RADIUS AND SCAPHOID FRACTURE (RIGHT) NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2275761 CARB-BITE CRILE-WOOD NH 8 CARDIOVASCULAR NEEDLE HOLDERS DWS INTEGRA LIFESCIENCES MANSFIELD 121132 100084-1703 10381780377139

    Patients

    Seq Age Sex Outcome Treatment
    1 Male