BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG

    MDR report key: 3201199 · Received July 2, 2013

    Report

    Report Number
    1719045-2013-01747
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS REVEALED THE T-HANDLE T25 STARDRIVE WAS MANUFACTURED BY UNIVERSAL PUNCH. PO (B)(4) FOR (B)(4) PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER (B)(4) REVISION F ON (B)(4) 2011. THE CERTIFICATE OF COMPLIANCE WAS DATED (B)(4) 2011. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON (B)(4) 2011. NO NON CONFORMANCES WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE REAMING T-HANDLE T25 STARDRIVE WAS MADE TO THE DRAWING (B)(4) RELEASED ON (B)(4) 2010.

    Additional Manufacturer Narrative · 1

    STARDRIVE IS DAMAGED, TIP IS MISSING. COSMETICALLY, SURFACE QUALITY IS SUBSTANDARD, APPEARING USED AS INDICATED BY RANDOM SURFACE BLEMISHES AND DEGRADED ETCH DETAIL. THE PRINCIPAL GEOMETRY AND STARDRIVE TAPER DEPTH COULD NOT BE EVALUATED FOR THIS COMPLAINT DUE TO MISSING TIP. THEREFORE THIS COMPLAINT IN INDETERMINATE FROM A MANUFACTURING STANDPOINT. REPORTED IN ERROR ON INITIAL REPORT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PRODUCT DEVELOPMENT EVALUATION: AS RECEIVED CONDITION: THE RETURN INCLUDES STRIPPED LOBES AND A DEFORMED DRIVER AT THE DISTAL TIP. THE DIRECTION OF THE DEFORMATION (TWISTING) IS CONSISTENT WITH REMOVING IMPLANTS. THE RETURN DID INCLUDE SOME OF THE METAL FRAGMENTS. THE REMAINDER OF THE INSTRUMENT IS IN EXCELLENT CONDITION. DESIGN EVALUATION: THE MATRIX SPINE SYSTEM INCLUDES A LONG T-HANDLE T25 DRIVER (03.632.074) TO INSERT PEDICLE SCREWS AND LOCKING CAPS (04.632.000). THIS INSTRUMENT IS NOT INTENDED FOR LOCKING CAP FINAL TIGHTENING OR LOOSENING. THE CHU REVIEWED THE ASSOCIATED DRAWINGS. THE DRAWINGS DETAIL THE APPROPRIATE DIMENSIONS, MATERIAL, DRIVER PROFILE, AND FINISHING PROCESSES FOR A SUCCESSFUL T25 DRIVER. A SHEAR CALCULATION 2.8MM FROM THE DISTAL TIP SHOWS THE TIP YIELDING AT 12 NM ¿ CLINICALLY ACCEPTABLE FOR INSERTING SCREWS AND LOCKING CAPS. THE DRIVER YIELDED AND STRIPPED DUE TO EXCESSIVE TORQUE WHEN REMOVING A LOCKING CAP. ACCORDING TO THE TECHNIQUE GUIDE, THIS INSTRUMENT IS NOT INTENDED TO REMOVE LOCKING CAPS. THE CHU REVIEWED CONSOLIDATED RISK ANALYSIS OF THE MATRIX STAR DRIVERS ADEQUATELY ADDRESSES THE HAZARD OF THIS COMPLAINT. THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    INITIAL THORACIC LUMBAR FUSION SURGERY OCCURRED ON (B)(6) 2011, APPROXIMATELY T10 TO L5. ON (B)(6) 2013, THE PATIENT UNDERWENT SURGERY TO REMOVE THE HARDWARE AT HER REQUEST DUE TO COMPLETE FUSION. THE SURGEON REMOVED 18 SCREWS, 17 LOCKING CAPS AND 2 RODS. IN ATTEMPTING TO REMOVE THE 18TH LOCKING CAP, 3 DIFFERENT SCREW DRIVER TIPS BROKE. ALL 3 PIECES WERE RETRIEVED, VERIFIED BY X-RAY. THE SURGEON WAS UNABLE TO REMOVE THE 18TH LOCKING CAP. THEREFORE, HE USED ROD CUTTERS TO CUT THE ROD ABOVE AND BELOW THE LOCKING CAP TO ALLOW ALL HARDWARE TO BE REMOVED. IT WAS NOTED THAT MOST OF THE CAPS CAME OUT FINE ALTHOUGH; SOME WERE HARDER TO REMOVE THAN OTHERS. SURGERY WAS PROLONGED APPROXIMATELY 5 TO 10 MINUTES. PATIENT REPORTEDLY WAS DOING FINE WITH NO OTHER ISSUES NOTED. THIS IS 1 OF 4 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301772 T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG HXX SYNTHES MONUMENT 6495491

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR