BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLA ILIAC SCREW PROBE STARTER

    MDR report key: 3803151 · Received May 9, 2014

    Report

    Report Number
    1526439-2014-11499
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HXB
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 ISOLA ILIAC PROBE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE PROBE HAD FRACTURED AT ITS DISTAL TIP, THE SECOND HALF OF THE TIP WAS NOT PROVIDED WITH THE DEVICE. SCANNING ELECTRON MICROSCOPY (SEM) FOUND EVIDENCE OF PLASTIC DEFORMATION AND A ROUGH/GRAINY FRACTURE TEXTURE, INDICATING A STATIC BENDING FRACTURE. ADDITIONALLY, THIS ANALYSIS FOUND NO MATERIAL DEFECTS OR OTHER ABNORMALITIES. BASED ON THE AGE OF THE DEVICE AND THE SEM ANALYSIS, THE FRACTURE IS NOT RELATED TO A MATERIAL DEFECT NOR MANUFACTURING ISSUE AND AS SUCH A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IS DEEMED NOT NECESSARY. A 12 MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE ISOLA PROBE WAS CONDUCTED ON THE SPECIFIC CODE FROM THE COMPLAINT AS THERE IS NO DEVICE FAMILY FOR THIS INSTRUMENT. THIS ANALYSIS FOUND NO EMERGING TRENDS. THE ROOT CAUSE OF THE ISOLA ILIAC PROBE¿S DISTAL TIP BECOMING FRACTURED CANNOT POSITIVELY BE DETERMINED. HOWEVER, THE SEM FRACTURE ANALYSIS RESULTS SHOW EVIDENCE OF PLASTIC DEFORMATION AND A ROUGH/GRAINY TEXTURE, INDICATING A STATIC BENDING FRACTURE AT THE DISTAL TIP OF THE PROBE. NO CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) IS NECESSARY AT THIS TIME AS THERE HAVE BEEN NO MATERIAL DEFECTS OR OTHER ABNORMALITIES OBSERVED IN THE FRACTURE ANALYSIS REPORT. ADDITIONALLY, NO OBSERVED SYSTEMIC TRENDS WERE IDENTIFIED. THEREFORE, 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

    INTERNATIONAL AFFILIATE REPORTS THAT DURING POSTERIOR FUSION FOR CORRECTION OF IDIOPATHIC SCOLIOSIS WITH EXPEDIUM 5, THE TIP OF THE PROBE SNAPPED OFF IN THE PEDICLE OF THE PATIENT. THE BROKEN TIP WAS REMOVED FROM THE PEDICLE WITH A RESULTING DELAY OF TWENTY MINUTES TO THE PROCEDURE. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE BROKEN TIP WAS LOST AT THE HOSPITAL AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281386 ISOLA ILIAC SCREW PROBE STARTER PROBE HXB DEPUY SYNTHES SPINE H0701

    Patients

    Seq Age Sex Outcome Treatment
    1