BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T25/SHORT/6MM HXC

    MDR report key: 3201198 · Received July 2, 2013

    Report

    Report Number
    1719045-2013-01748
    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. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT EVENT EVALUATION: THE PANGEA SPINE SYSTEM OFFERS THREE T25 DRIVERS WITH A HEX COUPLING (03.620.002, 03.620.003, AND 03.620.022) FOR INSTALLING PEDICLE SCREWS AND LOCKING CAPS (04.620.000). 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 TIGHTENING LOCKING CAPS. THE DRIVER YIELDED AND STRIPPED DUE TO EXCESSIVE TORQUE WHEN REMOVING A LOCKING CAP IN A MATRIX SYSTEM CASE. ACCORDING TO THE MATRIX TECHNIQUE GUIDE, THE SURGEON USES A 10 NM TORQUE LIMITING HANDLE WHEN REMOVING LOCKING CAPS. THE DEFORMATION SUGGESTS THE SURGEON DID NOT USE THE TORQUE LIMITING HANDLE. THE CHU REVIEWED RISK ANALYSIS ADEQUATELY ADDRESSES THE HAZARD OF THIS COMPLAINT. THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT 5143771 REVEALED THE STARDRIVE SCREWDRIVER SHAFT WAS MANUFACTURED BY UNIVERSAL PUNCH. PO 617749, FOR (B)(4) PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER 03II620022 REVISION A ON 4/6/06. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE (C OF C) IS DATED 4/3/06. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON 4/7/06. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ITEM RETURNED WITH THE COMPLAINT EXHIBITS GENERALLY DEGRADED, AS USED, SURFACE COSMETICS; DISCOLORATION ABOUT THE SHAFT AND FADED ETCH. STARDRIVE GEOMETRY IS INCOMPLETE AT THE TIP AND SPLINES APPEAR DISTORTED. BURRING IS ALSO PRESENT ON THE STARDRIVE. DUE TO THE SIGNIFICANT DAMAGE TO THE STARDRIVE, RELIABLE AND ACCURATE MEASUREMENTS COULD NOT BE OBTAINED.

    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 2 OF 4 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303283 STARDRIVE SCREWDRIVER SHAFT T25/SHORT/6MM HXC HXX SYNTHES MONUMENT 5143771

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR