BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM SINGLE-INNER SETSCREW

    MDR report key: 3103059 · Received May 9, 2013

    Report

    Report Number
    1526439-2013-16846
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK033901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION REVEALED THAT THERE WERE NO DEFECTS OR ABNORMALITIES. HOWEVER, IT WAS NOTED THAT ONE (1) SINGLE INNER SET SCREW LOT NO: NW113737 REVEALED TORN THREADS CONFIRMING THE COMPLAINT EVENT DESCRIPTION. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD¿VE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A REVIEW WITH PRODUCT DEVELOPMENT MANAGER WAS DIRECTED AND NO DEFINITIVE CONCLUSIONS WERE DRAWN. HOWEVER, IT WAS NOTED THAT PER SURGICAL TECHNIQUE WHEN USING THE SINGLE INNIE INSERTER, PICK UP AN INNIE FROM THE CADDY. USE THE ALIGNMENT GUIDE TO HELP POSITION THE HEAD AND REDUCE THE CHANCE OF CROSS-THREADING. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND 12 RELATED COMPLAINTS FOR PRODUCT CODE. A FURTHER REVIEW OF THE SALES AND COMPLAINT DATA OF A 12 MONTH TO DATE PERIOD FOUND THE OBSERVED (B)(4) TO BE DEEMED ACCEPTABLE WITHIN OUR INTERNAL RISK ASSESSMENT OCCURRENCE RATE OF THE DESIGN FAILURE MODE AND EFFECTS ANALYSIS. FURTHERMORE, THERE WERE NO RELATED COMPLAINTS OF SET SCREW STRIPPING FOR THE REPORTED LOT CODES. THE ROOT CAUSE OF THE SET SCREW BECOMING TORN CANNOT POSITIVELY BE DETERMINED. HOWEVER, AS REPORTED AN ALIGNMENT GUIDE WAS USED TO TIGHTEN THE SCREW. PER SURGICAL TECH, USE THE ALIGNMENT GUIDE TO HELP POSITION THE HEAD AND REDUCE THE CHANCE OF CROSS-THREADING. ADDITIONALLY, THE ANTI-TORQUE SLEEVE SHOULD BE USED FOR FINAL TIGHTENING. THEREFORE, IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT WHILE TIGHTENING THE SET SCREW, THREADS WERE DETACHED FROM THE DEVICE. THE SET SCREW AND ITS TORN THREADS WERE REMOVED FROM THE SURGICAL SITE WITHOUT ISSUE. THE DIFFICULTY DID NOT RESULT IN ANY ADVERSE CONSEQUENCES OR DELAY TO THE PROCEDURE. CONCOMITANT DEVICES: ADDITIONAL EXPEDIUM SINGLE-INNER SET SCREWS, (B)(4), QTY = 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203372 EXPEDIUM SINGLE-INNER SETSCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE NW113737

    Patients

    Seq Age Sex Outcome Treatment
    1