BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC PEDICLE PROBE, CURVED

    MDR report key: 4936500 · Received July 23, 2015

    Report

    Report Number
    1526439-2015-10656
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 29, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HXB
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE EXPEDIUM THORACIC PEDICLE PROBE ¿ CURVED [PRODUCT CODE: 2797-02-040] WAS NOT RETURNED FOR EVALUATION. DHR REVIEW COULD NOT BE CONDUCTED FOR THIS DEVICE AS THE LOT NUMBER IS UNKNOWN. LOT NUMBER WAS NOT PROVIDED. AS A RESULT, WITHOUT THE LOT NUMBER, A REVIEW OF THE MANUFACTURING RECORDS CANNOT BE PERFORMED. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. WITHOUT THE DEVICE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. NO ISSUES COULD HAVE BEEN IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE AS THE LOT NUMBER IS UNKNOWN. A TREND ANALYSIS WAS CONDUCTED. NO FURTHER ACTIONS FROM TRENDING ANALYSIS ARE REQUIRED; THEREFORE THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE DEVICE IS RETURNED AT A LATER DATE, THEN THIS COMPLAINT WILL BE REOPENED AND THE SAMPLE WILL BE EVALUATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. SAMPLE NOT RETURNED.

    Description of Event or Problem · 1

    INSTRUMENT BROKE DURING SURGERY. DR (B)(6) WAS USING THE EXPEDIUM PEDICLE PROBE CURVED TO MAKE HIS PREPARATION FOR THE PEDICLE SCREW. AS HE WAS DOING THIS, HE BROKE THE TIP OF THE PROBE OFF. THE TIP WAS REMOVED WITHOUT INCIDENT FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479413 THORACIC PEDICLE PROBE, CURVED PROBE HXB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1