BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR STRAIGHT PROBE

    MDR report key: 5205032 · Received November 5, 2015

    Report

    Report Number
    1526439-2015-10907
    Event Type
    Malfunction
    Date Received
    November 5, 2015
    Date of Event
    October 13, 2015
    Report Date
    October 13, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    OLO
    PMA / PMN Number
    PK120867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    ADDITIONAL INFORMATION (B)(4). ONE (1) IGS STRAIGHT LUMBAR PROBE [PRODUCT CODE: 2797-02-010N, LOT NO: GM38990PP] WAS RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU) FOR EVALUATION. VISUAL EXAMINATION AT THE MACROSCOPIC LEVEL REVEALED THAT THE FRACTURE WAS LOCATED AT THE PROBE¿S DISTAL TIP. THE FRACTURE ANALYSIS REPORT SHOWS EVIDENCE OF PLASTIC DEFORMATION FOLLOWING A CIRCULAR PATTERN AND A ROUGH APPEARANCE ACROSS THE ENTIRE SURFACE, INDICATING THAT THE PROBE UNDERWENT A STATIC TORSIONAL FAILURE. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. THE ROOT CAUSE FOR THE PROBE¿S DISTAL TIP BECOMING BROKEN CANNOT BE POSITIVELY DETERMINED. HOWEVER, THE FRACTURE ANALYSIS REPORT SHOWS EVIDENCE OF PLASTIC DEFORMATION FOLLOWING A CIRCULAR PATTERN AND A ROUGH APPEARANCE ACROSS THE ENTIRE SURFACE, INDICATING THAT THE PROBE UNDERWENT A STATIC TORSIONAL FAILURE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PLIF PROCEDURE. WHILE USING THE INSTRUMENT TO PROBE DOWN THE PEDICLE, WHEN PULLED THE INSTRUMENT BACK OUT IT WAS BROKEN INSIDE THE PATIENT. APPROX 1 CM OF INSTRUMENT WAS LEFT IN THE VERTEBRAL BODY. THE SURGEON CONTINUED ON AND PLACED A SCREW INTO THE VERTEBRAL BODY. HE LEFT PART OF THE INSTRUMENT IN THE VERTEBRAL BODY AS HE COULD NOT REMOVE IT. 5 MINUTES DELAY TO SURGERY. SURGEON BELIEVES THIS WILL NOT AFFECT THE PATIENT. PATIENT OUTCOME POST SURGERY NOT YET KNOWN. DISCARDED: NO RETURN TO MANUFACTURER UNLESS LOCAL ENGINEERING ASSESSMENT INDICATES RETURN IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734047 LUMBAR STRAIGHT PROBE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO DEPUY SYNTHES SPINE GM38990PP

    Patients

    Seq Age Sex Outcome Treatment
    1