BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOUNTAINEER MINIPOLYAXIAL SCREWDRIVER

    MDR report key: 4092597 · Received September 16, 2014

    Report

    Report Number
    1526439-2014-11902
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (1) MINIPOLYAXIAL SCREWDRIVER WAS RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU) FOR EVALUATION. VISUAL EXAMINATION REVEALED THAT THE FRACTURE WAS LOCATED AT THE DRIVER¿S DISTAL TIP. DEVICE WAS SENT FOR FRACTURE ANALYSIS. THE FRACTURED SURFACE REVEALED PLASTIC DEFORMATION AT THE HEX FEATURES AND TORSIONAL SHEAR MARKINGS AT THE CENTER OF THE PART FOLLOWING A CIRCULAR PATTERN, INDICATING A TORSIONAL OVERLOAD. THIS SUGGESTS THE DRIVER UNDERWENT A QUASI-STATIC SHEAR FAILURE STARTING AT THE DRIVER HEX AND IS EXTENDED TO THE CENTER OF THE SHAFT, THE POTENTIAL FRACTURE TERMINATION SITE. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE MINIPOLYAXIAL SCREWDRIVER WAS CONDUCTED. NO ISSUES WERE IDENTIFIED IN THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. AS SUCH, PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. ADDITIONALLY, IT SHOULD BE NOTED THAT THIS DEVICE HAS BEEN IN THE FIELD FOR APPROXIMATELY FIVE (5) YEARS. A 12-MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE MINIPOLYAXIAL SCREWDRIVER WAS CONDUCTED. THE ANALYSIS DID NOT REVEAL ANY SYSTEMIC TRENDS REQUIRING FURTHER ACTION. THE ROOT CAUSE OF THE DRIVER TIP BECOMING BROKEN CANNOT POSITIVELY BE DETERMINED. HOWEVER, IT WAS IDENTIFIED IN THE FRACTURE ANALYSIS REPORT THAT THE DRIVER UNDERWENT A QUASI-STATIC SHEAR 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 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. 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

    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.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT DURING A LATERAL MASS FUSION PROCEDURE INVOLVING C6-T1, THE TIP OF THE MOUNTAINEER MINIPOLYAXIAL SCREWDRIVER SNAPPED OFF INTO THE HEAD OF A CONCOMITANT DEVICE SCREW THAT WAS BEING INSERTED. NO BITS FELL INTO THE PATIENT. THE SCREW CONTAINING THE BROKEN BITS WAS REMOVED AND A NEW SCREWDRIVER AND SCREW WERE USED TO PROCEED WITH THE PROCEDURE. THE RESULTING DELAY WAS TWENTY MINUTES WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571492 MOUNTAINEER MINIPOLYAXIAL SCREWDRIVER SCREWDRIVER HXX DEPUY SYNTHES SPINE X1108R

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW, CATALOG NO. UNKNOWN