BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNOWDEN-PENCER DIAMOND-TIP WIRE/PIN CUTTER

    MDR report key: 17958213 · Received October 18, 2023

    Report

    Report Number
    1423507-2023-00104
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    September 7, 2023
    Report Date
    October 18, 2023
    Manufacturer
    CAREFUSION INC.
    Product Code
    HXZ
    UDI-DI
    10885403146060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    V. MUELLER HAS REQUESTED THE DEVICE SUBJECT OF THE REPORTED EVENT BE RETURNED FOR EVALUATION. THE SNOWDEN-PENCER DIAMOND-TIP WIRE/PIN CUTTER INSTRUCTIONS FOR USE STATES, "INSPECTION/MAINTENANCE: INSPECT DEVICES BEFORE EACH USE FOR BROKEN, CRACKED, TARNISHED SURFACES, MOVEMENT OF HINGES, AND CHIPPED OR WORN PARTS. IF ANY OF THESE CONDITIONS APPEAR, DO NOT USE THE DEVICE. RETURN DEVICES TO AN AUTHORIZED REPAIR SERVICE CENTER FOR REPAIR OR REPLACEMENT." A 3-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE SNOWDEN-PENCER DIAMOND-TIP WIRE/PIN CUTTER WAS RETURNED TO THE SUPPLIER, XKA - KAPP SURGICAL GMBH FOR EVALUATION. THE EVALUATION INDICATED THAT THREE CHIPPINGS WERE NOTED ON THE CUTTING EDGE OF THE DEVICE. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, A METAL FLAKE FROM THEIR SNOWDEN-PENCER DIAMOND-TIP WIRE/PIN CUTTER FELL INTO THE PATIENT. THE METAL FLAKE WAS IMMEDIATELY REMOVED FROM THE PATIENT AND THE AREA WAS IRRIGATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178803 SNOWDEN-PENCER DIAMOND-TIP WIRE/PIN CUTTER WIRE/PIN CUTTER HXZ CAREFUSION INC. 32-2816 K22XKA 10885403146060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown