BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAIGHT TIP T25 DRIVER-LONG

    MDR report key: 3150173 · Received June 6, 2013

    Report

    Report Number
    8030965-2013-02781
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: TIP IS BROKEN OFF, FRAGMENTS WERE NOT SENT BACK. THE RELEVANT DIMENSIONS CAN NOT BE VERIFIED ANYMORE BECAUSE OF THE DAMAGE AND BECAUSE THE BROKEN FRAGMENTS WERE NOT SENT BACK FOR INVESTIGATION. THEREFORE THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. AS INDICATED IN THE MANUFACTURING DOCUMENTS THE CORRECT MATERIAL WAS USED AND THE HARDNESS WAS WITH WITHIN THE SPECIFICATION. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. BASED ON THE TWISTED AND SKEWED APPEARANCE OF THE FRACTURE FACE IT CAN BE ASSUMED THAT A MECHANICAL OVERLOAD BY APPLYING TOO MUCH TORQUE IN COMBINATION WITH LATERAL STRESS CAUSED THE BREAKAGE. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. LEGACY SYNTHES OFFERS TWO DIFFERENT LENGTH STRAIGHT TIP DRIVERS (03.632.400 AND 03.632.401) TO INSERT PEDICLE SCREWS, FINAL TIGHTEN LOCKING CAPS, AND LOOSEN LOCKING CAPS FOR THE MATRIX SPINE SYSTEM. NO CURRENT MATRIX TECHNIQUE GUIDE INCLUDES THESE PART NUMBERS. THE TECHNIQUE GUIDES DETAIL THE APPROPRIATE INSTRUMENTS AND TECHNIQUE FOR LOOSENING LOCKING CAPS (04.632.000). THE CHU REVIEWED THE PRODUCT DRAWING. THE DRAWING DETAILS THE APPROPRIATE DIMENSIONS, MATERIAL, DRIVER PROFILE, AND FINISHING PROCESSES FOR A SUCCESSFUL T25 DRIVER SHAFT. BASED ON MECHANICAL TESTING, FAILURE OF THE DRIVER TIP OCCURS AT 20NM. IN ADDITION, THE COMPLAINT DESCRIPTION DOES NOT INCLUDE ANY DETAIL OF THE SURGEON PROPERLY USING THE 10NM TORQUE LIMITING HANDLE. THIS INFORMATION SUGGESTS THE USER DID NOT USE THE TORQUE LIMITING HANDLE AND SHEARED THE DRIVER TIP WHILE TRYING TO LOOSEN A LOCKING CAP. ALTHOUGH THE FRACTURED TIP OF THE 03.632.400 AND 03.632.401 MAY BE THE RESULT OF NOT USING A TORQUE-LIMITING HANDLE, THESE STRAIGHT TIP DRIVERS ARE NOT DESCRIBED IN THE PRODUCT LITERATURE. SINCE THE TECHNIQUE GUIDE DOES NOT EXPLAIN HOW THESE DRIVERS SHOULD BE USED FOR LOOSENING LOCKING CAPS, THE DISPOSITION FOR THIS COMPLAINT FROM A DESIGN PERSPECTIVE IS VALID. PLACEHOLDER. (B)(4)

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH HARDWARE ON (B)(6) 2013 FOR A TWO-LEVEL VERTEBRAL SPACER TR SURGERY AT L3-L5 LEVELS. PATIENT PRESENTED WITH PAIN. X-RAY TAKEN ON AN UNSPECIFIED DATE REVEALED THE TWO MATRIX SCREWS AT L3 BACKED OUT. FOR THE INITIAL SURGERY, IT WAS REPORTED THE SURGEON PACKED BONE AND THE SPACER WAS BEHIND THE BONE GRAFT; THE SPACER SHIFTED. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 FOR REVISION SURGERY. REPORTEDLY WHILE THE SURGEON WAS REMOVING THE L4 LOCKING CAP ON THE LEFT SIDE OF THE SPINE USING THE STRAIGHT TIP DRIVER T25, THE TIP OF THE DRIVER BROKE. SURGEON REMOVED THE FRAGMENT WITH A PITUITARY INSTRUMENT. THE SURGEON TRIED TO REMOVE THE LOCKING CAP WITH ANOTHER STRAIGHT TIP DRIVER T25 AND THE TIP OF THE DRIVER BROKE. THE SURGEON WAS REMOVED THE FRAGMENT WITH A BAYONET INSTRUMENT. THE SURGEON THEN TRIED TO REMOVE THE LOCKING CAP WITH A T-HANDLE STARDRIVE SHAFT AND THE SHAFT BROKE IN HALF. IT WAS REPORTED WHILE THE SURGEON WAS USING THE ROD BENDER WITH SILICONE HANDLES FOR CONTOURING THE NEW RODS, THE HANDLES BECAME STUCK. ANOTHER INSTRUMENT WAS USED TO BEND THE RODS. THE SURGEON REMOVED THE T-PLIF SPACER, SCREWS, AND RODS AT L3-4 LEVEL. REPORTEDLY THE T-PLIF SPACER WAS REMOVED DUE TO THE IMPLANT SHIFTING. THE PATIENT WAS REVISED WITH TWO NEW SCREWS AND RODS. TWO ADDITIONAL SCREWS WERE ADDED TO THE CONSTRUCT AT THE ILEUM LEVEL. REPORTEDLY THERE WAS EXTENDED TIME OF TWO HOURS DUE TO THE DEVICE MALFUNCTION. THIS IS 1 OF 9 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250071 STRAIGHT TIP T25 DRIVER-LONG HXX SYNTHES GMBH 7663291

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention