BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIPOLYAXIAL SCREWDRIVER

    MDR report key: 3953006 · Received July 23, 2014

    Report

    Report Number
    1526439-2014-11707
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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 MINIPOLYAXIAL SCREWDRIVER WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE FRACTURE WAS LOCATED AT THE DRIVER¿S DISTAL TIP. THE SECOND HALF OF THE TIP WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. FRACTURE ANALYSIS FOUND EVIDENCE OF A TORSIONAL OVERLOAD. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12 MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE MINIPOLYAXIAL DRIVER WAS CONDUCTED ON THE SPECIFIC CODE FROM THE COMPLAINT AS THERE IS NO DEVICE FAMILY FOR THIS INSTRUMENT. THIS ANALYSIS FOUND NO SYSTEMIC TRENDS THAT REQUIRE ADDITIONAL ACTION. THE ROOT CAUSE OF THE SCREWDRIVER¿S DISTAL TIP BREAKING INTRA-OPERATIVELY CANNOT POSITIVELY BE DETERMINED. HOWEVER, THE OPTICAL IMAGES IDENTIFIED IN THE FRACTURE ANALYSIS REPORT REVEAL PLASTIC DEFORMATION AT THE HEX FEATURES OF THE DEVICE INDICATING A TORSIONAL OVERLOAD. THIS SUGGESTS THE DRIVER UNDERWENT A QUASI-STATIC SHEAR FAILURE. NO CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) IS NECESSARY AT THIS TIME AS THERE HAVE BEEN NO ISSUES IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS SCREWDRIVER. ADDITIONALLY, NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. 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.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: FEB-22-2005, MAR-24-2005, MAR-28-2005. 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

    SALES REP REPORTS THE TIP OF AN UNIDENTIFIED DEPUY SYNTHES SPINE SCREWDRIVER BROKE OFF FROM THE INSTRUMENT, FLUSH WITHIN THE SHANK OF A SCREW THAT WAS IMPLANTED. A ROD WAS PLACED IN THE SCREW HEAD, OVER THE BROKEN TIP, AND A SET SCREW WAS ASSEMBLED OVER THE ROD AND BROKEN DRIVER TIP. A REQUEST HAS BEEN MADE FOR ADDITIONAL PRODUCT, PATIENT, AND CUSTOMER INFORMATION. HOWEVER, THE REQUESTED INFORMATION HAS NOT BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430052 MINIPOLYAXIAL SCREWDRIVER SCREWDRIVER HXX DEPUY SYNTHES SPINE X0205

    Patients

    Seq Age Sex Outcome Treatment
    1 PEDICLE SCREW, CATALOG NO. UNKNOWN| SET SCREW, CATALOG NO. UNKNOWN| ROD, CATALOG NO. UNKNOWN