BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-STANDARD

    MDR report key: 4077141 · Received September 10, 2014

    Report

    Report Number
    1719045-2014-10429
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 12, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DHRS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION REVIEW OF THE DHRS FOR P/N 03.632.004, LOT 6726495, SHOWED NO NONCONFORMANCES GENERATED DURING PRODUCTION. 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 PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT: THE T-HANDLE T25 STARDRIVE SHAFT FOR MATRIX (03.632.004 LOT 6726495) IS A COMPONENT OF THE MATRIX DEFORMITY BASIC INSTRUMENT SET (01.632.015) WHICH IS USED FOR THE MATRIX SPINE SYSTEM. THE MATRIX SPINE SYSTEM ¿ DEGENERATIVE IS A ¿COMPREHENSIVE THORACOLUMBAR PEDICLE SCREW SYSTEM DESIGNED TO PROVIDE FLEXIBILITY, BIOMECHANICAL PERFORMANCE AND A TOTAL SOLUTION TO COMPLEX POSTERIOR PATHOLOGICAL CHALLENGES¿. THE T-HANDLE T25 DRIVER IS SPECIFICALLY DESIGNED TO TIGHTEN AND LOOSEN LOCKING CAPS WHICH SECURE RODS INTO POLYAXIAL AND OR PEDICLE SCREWS (MATRIX SPINE SYSTEM ¿ DEGENERATIVE J9699-D). A TOP-LEVEL DRAWING FOR THE T-HANDLE T25 STARDRIVE SHAFT WAS REVIEWED (03_632_004 REV C). THIS DRAWING WAS FOUND SUITABLE TO DETERMINE THE INTENDED DEVICE DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY. THE DRIVER WAS FOUND TO HAVE MET THE DRAWING SPECIFICATIONS. THE T-HANDLE T25 STAR DRIVE SHAFT FOR MATRIX (03.632.004 LOT 6726495) IS A COMPONENT OF THE MATRIX DEFORMITY BASIC INSTRUMENT SET (01.632.015) WHICH IS USED FOR THE MATRIX SPINE SYSTEM. THE MATRIX SPINE SYSTEM ¿ DEGENERATIVE IS A ¿COMPREHENSIVE THORACOLUMBAR PEDICLE SCREW SYSTEM DESIGNED TO PROVIDE FLEXIBILITY, BIOMECHANICAL PERFORMANCE AND A TOTAL SOLUTION TO COMPLEX POSTERIOR PATHOLOGICAL CHALLENGES¿. THE T-HANDLE T25 DRIVER IS SPECIFICALLY DESIGNED TO TIGHTEN AND LOOSEN LOCKING CAPS WHICH SECURE RODS INTO POLYAXIAL AND OR PEDICLE SCREWS (MATRIX SPINE SYSTEM ¿ DEGENERATIVE J9699-D). THE PRODUCT WAS RECEIVED UNDER THE COMPLAINT CONDITION ¿STICKS/JAMS/STUCK¿. THE DRIVER TIP IS ROUNDED AND WORN. THIS INSTRUMENT WAS MANUFACTURED IN 2011 AND HAS BEEN IN SERVICE FOR THREE YEARS. THE TIP BECOMING WORN OR ROUNDED IS TYPICAL WEAR AND TEAR FOR THIS TYPE OF DEVICE, BUT IT CAN BE ACCELERATED THROUGH THE USE OF EXCESS TORQUE. THIS INSTRUMENT IS AN ¿ALSO AVAILABLE¿ INSTRUMENT FOR THE APPLICATION. THE RECOMMENDED DRIVERS ARE COMPATIBLE WITH A TORQUE LIMITING HANDLE TO PREVENT THE APPLICATION OF EXCESSIVE TORQUE. THE T-HANDLE DRIVERS ARE OFTEN UTILIZED FOR THE REMOVAL OF IMPLANTS, AS WAS THE CASE IN THIS COMPLAINT. THE TIP BECOMING STRIPPED AFTER ONLY THREE YEARS OF USE IS LIKELY A RESULT OF THE APPLICATION OF EXCESSIVE TORQUE. AFTER REVIEWING THE RELATED PRODUCT DRAWINGS, COMPLAINT HISTORY AND RISK ANALYSIS, THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PRODUCT DID FAIL, SO THE COMPLAINT IS CONFIRMED. THE FAILURE IS CONSISTENT WITH WEAR AND TEAR, HOWEVER BASED ON THE DEVICE AGE, IT IS LIKELY THAT THE WEAR WAS ACCELERATED THE APPLICATION OF EXCESSIVE TORQUE WHEN INSERTING/REMOVING THE LOCKING CAPS. THIS EXCESSIVE TORQUE WOULD CAUSE THE TIP TO STRIP. THE DEVICE IS THEREFORE DETERMINED TO BE SUITABLE FOR ITS INTENDED USE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    IT WAS REPORTED THAT ON (B)(6) 2014 DURING A SURGERY ON (B)(6) 2014 FOR HARDWARE REMOVAL OF MATRIX CORTICAL (DUAL) SCREWS, THREE LOCKING CAPS STRIPPED. THE HARDWARE, A MATRIX SCREW AND LOCKING CAP, WERE REMOVED PER PHYSICIAN'S PROTOCOL. THE PATIENTS BONES HAD FUSED/HEALED PER RADIOGRAPHS AND THEREFORE UNDERWENT HARDWARE REMOVAL ON (B)(6) 2014. IT WAS REPORTED 4 SCREWDRIVERS STRIPPED WHILE TRYING TO REMOVE THE SCREW AND LOCKING CAP (NO PRODUCT CODE OR LOT NUMBER AVAILABLE FOR THE SCREW AND CAP AS THEY WERE DISCARDED). THE SCREWDRIVERS APPEARED TO "COLD FUSE/WELD TOGETHER" AND ONE OF THE FOUR DRIVERS' (B)(4) TIP BROKE. THE FRAGMENT WAS RETRIEVED BY THE SURGEON. THE OPERATION WAS DELAYED 15 MINUTES. THE HARDWARE WAS SUCCESSFULLY REMOVED AND THE PATIENT HAS RECOVERED. THIS REPORT IS 4 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557749 T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-STANDARD SCREWDRIVERS HXX SYNTHES MONUMENT 6726495

    Patients

    Seq Age Sex Outcome Treatment
    1