BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL SPACER HANDLE

    MDR report key: 4366793 · Received December 29, 2014

    Report

    Report Number
    1719045-2014-10707
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Date of Event
    December 1, 2014
    Report Date
    December 1, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.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.

    Additional Manufacturer Narrative · 1

    SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE HANDLE BROKE OFF FROM THE TRIAL. THE REPAIR TECHNICIAN REPORTED THE SPINDLE ASSEMBLY TIP BROKE OFF. TIP BROKEN IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. PRODUCT INVESTIGATION EVALUATION: ONE TRIAL SPACER HANDLE (PART 389.151 LOT 57933) ALONG WITH ONE TRIAL SPACER (03.802.000 LOT 2162106) WAS RETURNED TOGETHER WITH A COMPLAINT DESCRIPTION OF ¿DURING AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE, THE TRIAL HANDLE BROKE OFF FROM THE ACTUAL TRIAL.¿ THE TWO PARTS ARE USED TOGETHER FOR STAND-ALONE ANTERIOR LUMBAR INTERBODY FUSION PROCEDURES INDICATED FOR PATIENTS WITH DEGENERATIVE DISC DISEASE. INDICATIONS ARE PROVIDED TO USE PRE-OPERATIVE PLANNERS FOR PROPER PARTS SELECTION AS WELL AS STEP BY STEP EXPLANATIONS ARE DESCRIBED INCLUDING RECOMMENDATIONS AND PRECAUTIONS. A TRIAL SPACER MAY BE USED AS A TEMPLATE TO FACILITATE THE SELECTION OF THE TRIAL IMPLANT. A TRIAL SPACER HANDLE IS ATTACHED AND CONTROLLED LIGHT HAMMERING ON THE HANDLE MAY BE APPLIED TO ADVANCE THE TRIAL SPACER INTO THE DISC SPACE. THE RETURNED DEVICE (LOT 57933) WAS RELEASED TO THE WAREHOUSE IN OCTOBER 2006. THE TRIAL SPACER HANDLE WAS RECEIVED WITH THE TIP OF THE SPINDLE ASSEMBLY BROKEN OFF AND EMBEDDED IN THE ORIFICE OF THE TRIAL SPACER (03.802.000). THE ASSOCIATED DRAWINGS FOR THE HANDLE WERE REVIEWED; BOTH FROM THE TIME OF MANUFACTURE OF THE RETURNED INSTRUMENT AND THE MOST RECENT REVISION. THE DRAWINGS DETAIL THE APPROPRIATE DIMENSIONS, MATERIALS, AND FINISHING PROCESS FOR A SUCCESSFUL INSTRUMENT. SYNTHES BUILT THE FAILED COMPONENT FOR THIS INSTRUMENT TO A PREVIOUS DRAWING. THIS DRAWING CALLS OUT STAINLESS STEEL 440A WHICH WAS CHANGED TO CUSTOM 465 AS IT IS STRONGER. IN ADDITION, THE DRAWINGS FOR THE TRIALS WERE REVIEWED. THE DRAWINGS CALL OUT THE APPROPRIATE THREAD AND THREAD DEPTH TO FULLY SEAT THE SPINDLE ASSEMBLY; ADDITIONALLY NO CHANGES OR ISSUES WERE IDENTIFIED WITH MATERIAL AND FINISHING PROCESSES FOR A SUCCESSFUL TRIAL SPACER DEVICE DESIGN. THIS COMPLAINT FAILURE COULD HAVE BEEN CAUSED BY IMPROPER TECHNIQUE (USE OF HANDLE IN LOOSENED STATE, EXCESSIVE IMPACTION FORCE, CROSS THREADING) LEADING TO THE FRACTURE OF THE TRIAL SPACER HANDLE SPINDLE TIP. A DESIGN CHANGE TO THE SPINDLE SUBASSEMBLY WAS IMPLEMENTED TO ADDRESS THE BREAKAGE OF THE DISTAL TIP OF THE SPINDLE PRIOR TO THE MANUFACTURING OF THIS LOT. AS THIS INSTRUMENT WAS MANUFACTURED PRIOR TO THE DESIGN CHANGES THE COMPLAINT IS CONFIRMED AND DEEMED VALID FROM A DESIGN PERSPECTIVE. DEVICE 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.

    Additional Manufacturer Narrative · 1

    A SERVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 5-OCT-2006. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED.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.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 DURING AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE, THE TRIAL HANDLE BROKE OFF FROM THE ACTUAL TRIAL. THERE WAS A SURGICAL DELAY OF TEN TO FIFTEEN MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A DIFFERENT DEVICE. THE PATIENT OUTCOME POST-SURGERY IS GOOD. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854411 TRIAL SPACER HANDLE FORCEPS HTD SYNTHES MONUMENT 5347081

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR