BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOUGH STAPED FOOT PLATE PICK STRTIP 90DG

    MDR report key: 6613319 · Received June 5, 2017

    Report

    Report Number
    1423507-2017-00088
    Event Type
    Malfunction
    Date Received
    June 5, 2017
    Date of Event
    April 18, 2017
    Report Date
    June 5, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    JYT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): SUPPLIER LOT IDENTIFIED UPON RECEIPT OF COMPLAINT DEVICE AS LOT XFAX04 ON (B)(6) 2017. INSTRUMENT SUPPLIER NOTIFIED OF THE REPORTED COMPLAINT. AFTER SAMPLE DECONTAMINATION THE DEVICE FORWARDED TO SUPPLIER (B)(6) 2017. SUPPLIER CONFIRMED RECEIPT OF MDR COMPLAINT NOTIFICATION (B)(6) 2017. A SUPPLIER EVALUATION OF THE DEVICE IS ANTICIPATED BUT HAS NOT YET COMPLETED TO DATE. A FOLLOW UP MDR SUBMISSION WILL BE COMPLETED UPON RECEIPT OF DEVICE EVALUATION BY MANUFACTURER OR IF ANY ADDITIONAL INFORMATION IS PROVIDED FOR THE ISSUE BY THE CUSTOMER.

    Description of Event or Problem · 1

    MEDICAL SPECIALTIES - BROKEN; THE SALES REP REPORTED VIA EMAIL THAT THE INSTRUMENT BROKE DURING A CASE ON (B)(6) 2017. THE INSTRUMENT BROKE INSIDE A PATIENT AND THE BROKEN PIECE COULD NOT BE RETRIEVED DUE TO POTENTIAL RISK OF HEARING LOSS UPON REMOVAL. ADDITIONAL INFORMATION WAS PROVIDED (B)(6) 2017: THE INSTRUMENT PIECE HAS NOT BEEN RETRIEVED TO DATE. THE PROCEDURE BEING PERFORMED WHEN THE INSTRUMENT WAS BEING USED BROKE WAS A STAPEDECTOMY. THE RETAINED OBJECT IS THE TIP OF INSTRUMENT. THE OBJECT HAS NOT BEEN RETRIEVED TO DATE. AN X-RAY WAS NOT TAKEN, THE PHYSICIAN IS CONFIDENT THE PIECE RETAINED IN THE PATIENT AND IS SO SMALL COULD NOT BE PICKED UP WITH IMAGING. THE PROCEDURE WAS COMPLETED AS PLANNED. THE PATIENT CONDITION IS CURRENTLY UNKNOWN. ON (B)(6) 2017: INSTRUMENT RETURNED AND SUPPLIER IDENTIFIED. PRODUCTION LOT XFAX04 PHYSICALLY CONFIRMED. SUPPLIER HAS BEEN NOTIFIED OF THE COMPLAINT. DEVICE EVALUATION BY SUPPLIER ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394520 HOUGH STAPED FOOT PLATE PICK STRTIP 90DG STAPEDECTOMY FOOT PLATE PICK JYT CAREFUSION, INC AU20790 XFAX04

    Patients

    Seq Age Sex Outcome Treatment
    1 Other