BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3033509 · Received April 3, 2013

    Report

    Report Number
    1719045-2013-00869
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD REPORTS THE PRODUCT CONFORMED TO ALL REQUIREMENTS. IT SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES PART #03.616.043: THE HOLDING SLEEVE HAS MINIMAL DAMAGE TO THE THREADS. THE DEVICE STILL FUNCTIONS AS INTENDED AND RETAINS A MATRIX POLYAXIAL SCREW. THE DESIGN ALLOWS FOR TWO MODES OF OPERATION: ONE IS FOR INSERTION OF THE PEDICLE SCREW INTO THE PEDICLE AND ONE FOR THREADING THE SCREW FOR RETAINMENT. THE SCREW MAY HAVE BEEN SLIGHTLY OFF AXIS MAKING IT A LITTLE DIFFICULT TO THREAD ON THE SCREW DURING SURGERY. HOWEVER, THE NICKS ON THE THREADS DO NOT PREVENT THE HOLDING SLEEVE FROM ENGAGING THE SCREW THREADS. THE MATERIALS WERE REVIEWED AND ARE ADEQUATE FOR THE INTENDED USE. PART #03.632.400: THE DRIVER HAS A YIELDED AND FRACTURED TIP. THIS FAILURE OCCURRED DURING THE ATTEMPTED REMOVAL OF THE LOCKING CAP. THE COMPLAINT DESCRIPTION DOES NOT DESCRIBE WHETHER OR NOT THE TORQUE-LIMITING HANDLE WAS USED DURING REMOVAL. THE APPEARANCE OF THE FRACTURED TIP ON THE RETURNED ITEM MATCHES THE APPEARANCE OF DRIVERS THAT WERE TESTED IN A LABORATORY SETTING AT SYNTHES. IN THE LABORATORY TEST, YIELDING OCCURRED AT APPROXIMATELY 15NM, AND SHEARING OCCURRED AT GREATER THAN OR EQUAL TO 20NM. THIS SUGGESTS THAT THE RETURNED PART WAS SUBJECTED TO TORQUE AS HIGH AS 20NM. THE MATERIALS WERE REVIEWED AND ARE ADEQUATE FOR THE INTENDED USE. THE HOLDING SLEEVE FUNCTIONS AS INTENDED. THE 03.632.400 DRIVER MAY NOT HAVE BEEN USED WITH THE TORQUE-LIMITING HANDLE. HOWEVER, AS BOTH OF THESE INSTRUMENTS ARE NOT IN THE EXISTING TECHNIQUE GUIDES, AN INTERNAL CORRECTIVE ACTION DETERMINATION HAS BEEN OPENED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. RMS COMPANY MANUFACTURED THE LOCKING HOLDING SLEEVE -LONG, FOR MATRIX, PART (B)(4), LOT 6752160. THE LOT INITIALLY CONFORMED TO SPECIFICATIONS AND WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. DUE TO AN UNKNOWN CAUSE, THE THREADED TIP, M 6.5 X 0.75 - 3H 4H, IS DAMAGED AND CAN NOT BE MEASURED. THE COMPONENT PART(B)(4) EXHIBITS SCUFFMARKS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DURING L5-S1 LUMBAR FUSION PROCEDURE ON (B)(6) 2013, THE SURGEON WAS HALF WAY THROUGH PLACING A 7.0 MM TITANIUM MATRIX SCREW AT THE S1 LEVEL, A SMALL RING OF METAL AT THE TOP OF THE SCREW SNAPPED OFF, WHERE THE HOLDING SLEEVE CONTACTS THE SCREW. WHILE BACKING OUT THE SCREW, THE REPLACED SCREWDRIVER THREADS WERE DAMAGED. THE LOCKING HOLDING SLEEVE ALSO HAD THREADS DAMAGED AND WAS UNABLE TO BE USED. THE SURGEON USED ANOTHER SCREWDRIVER AND SUCCESSFULLY PLACED THE SCREW AT LEVEL S1. ONCE THE CONSTRUCT WAS FINISHED AND THE HEADS WERE PLACED INTO LOCKING CAPS AFTER FINAL TIGHTENING, THE SURGEON DECIDED TO REDIRECT ONE OF THE LOCKING CAPS. THE SURGEON WAS UNABLE TO REMOVE THE LOCKING CAP. WHILE TRYING TO REMOVE THE LOCKING CAP A STANDARD DRIVER AND A STARDRIVE SCREWDRIVER SHEARED OFF AND ANOTHER STARDRIVE SCREWDRIVER BECAME DEFORMED. THE SURGEON USED A METAL CUTTING BURR TO CUT THE ROD THAT STILL IS STUCK INSIDE THE HEAD OF THE SCREW AND USED A COUNTER TORQUE DEVICE TO REMOVE THE SCREW. ALL PARTS WERE RETRIEVED, THE PROCEDURE WAS DELAYED APPROXIMATELY ONE HOUR DUE TO THE EVENTS LISTED. THIS IS FOR A HOLDING SLEEVE-LONG. THIS IS REPORT 2 OF 8 PARTS FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    THIS IS 2 OF 8 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135756 LOCKING HOLDING SLEEVE-LONG FOR MATRIX LXH SYNTHES MONUMENT 6752160

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention