BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 147307 · Received January 6, 1998

    Report

    Report Number
    147307
    Event Type
    Malfunction
    Date Received
    January 6, 1998
    Date of Event
    December 22, 1997
    Report Date
    December 24, 1997
    Manufacturer
    DEPUY-ACE MEDICAL
    Product Code
    HXI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING SURGICAL PROCEDURE. PHYSICIAN UTILIZING K-WIRE 4" SIZE .045. UPON INSERTION OF K-WIRE INTO BONE, TIP OF K-WIRE BROKE OFF. UPON EXTRACTION OF ANOTHER 4" SIZE .045 TIP BROKE OFF. BOTH K-WIRES TIPS LEFT IN BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant K-WIRE HXI DEPUY-ACE MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other