BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM SINGLE-INNER SETSCREW

    MDR report key: 3495572 · Received December 2, 2013

    Report

    Report Number
    1526439-2013-34742
    Event Type
    Malfunction
    Date Received
    December 2, 2013
    Date of Event
    November 13, 2013
    Report Date
    November 13, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK111136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION SHOWS STRIPPING ON THE INTERNAL DRIVE FEATURE. IT WAS REPORTED TO THE FDA IN MDR-050105 THE MDR REFERENCES THE SET SCREW THREADS STRIPPING, HOWEVER ON VISUAL INSPECTION IT SHOWED THAT THE DRIVE FEATURE STRIPPED, NOT THE OUTER THREADS. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE SINGLE-INNER SETSCREW FOUND NO DISCREPANCIES DURING THE MANUFACTURING OF THE PRODUCT. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE BEEN CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPANYING ALL QUALITY REQUIREMENTS. REVIEW OF COMPLAINTS FOUND NO SIGNIFICANT TRENDS. THE ROOT CAUSE FOR THE SCREW HEAD COMING APART FROM THE SHANK CANNOT BE POSITIVELY IDENTIFIED. HOWEVER, IT IS MOST LIKELY DUE TO THE DRIVERS NOT BEING USED AT AN ANGLE AND PLACING EXCESSIVE FORCES ON THE SCREW HEAD. NO CORRECTIVE ACTION/PREVENTIVE ACTION IS REQUIRED AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE, AND THERE HAVE BEEN NO SYSTEMATIC TRENDS. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE THREADS OF AN EXPEDIUM SINGLE INNER SET SCREW WERE STRIPPED DURING INSERTION INTO A PEDICLE SCREW. ALSO, THE HEAD OF AND EXPEDIUM POLYAXIAL SCREW POPPED OFF/SEPARATED FROM ITS SCREW SHAFT INTRA-OPERATIVELY. LASTLY, THE DISTAL TIPS OF THREE CONCOMITANT DEVICES, AN EXPEDIUM QUICK CONNECT POLYAXIAL SCREWDRIVER, A T20 SCREWDRIVER SHAFT, AND A VIPER2 FINAL TIGHTENER DRIVER, ALL WERE STRIPPED DURING THE PROCEDURE. SEE MFG MEDWATCH REPORT NO. 1526439-2013-34743 FOR THE EXPEDIUM POLYAXIAL SCREW THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623123 EXPEDIUM SINGLE-INNER SETSCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE APLDLB

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR 279702050| 286745550| 279712400