BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL SPACER HANDLE

    MDR report key: 4902169 · Received July 9, 2015

    Report

    Report Number
    1719045-2015-10439
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 23, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED INSTRUMENTS WERE EVALUATED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE TRIAL HOLDER WAS MISSING THE DISTAL TIP AND THE EMBEDDED FRAGMENT WAS RETAINED BY THE TRIAL SPACER. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE IDENTIFIED; HOWEVER THE FAILURE MODE IS CONSISTENT WITH IMPROPER TECHNIQUE. ONE TRIAL SPACER HANDLE (PART 389.151, LOT 7212998) ALONG WITH ONE TRIAL SPACER (03.802.019 LOT 8082651) WERE RETURNED TOGETHER. PER THE TECHNIQUE GUIDE, THE TWO PARTS ARE USED TOGETHER FOR STAND-ALONE ANTERIOR LUMBAR INTERBODY FUSION PROCEDURES INDICATED FOR PATIENTS WITH DEGENERATIVE DISC DISEASE. 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 7212998) WAS RELEASED TO THE WAREHOUSE IN MARCH 2013. THE TRIAL SPACER HANDLE WAS RECEIVED WITH THE TIP OF THE SPINDLE ASSEMBLY BROKEN OFF AND EMBEDDED IN THE THREADED PORTION OF THE TRIAL SPACER (03.802.016). THE ASSOCIATED DRAWINGS OF THE CURRENT RELEASE WERE REVIEWED. THE DRAWINGS DETAIL THE APPROPRIATE DIMENSIONS, MATERIALS, AND FINISHING PROCESS FOR A SUCCESSFUL INSTRUMENT. 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. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE IDENTIFIED, HOWEVER THE FAILURE MODE IS CONSISTENT WITH IMPROPER TECHNIQUE (USE OF HANDLE IN LOOSENED STATE, EXCESSIVE IMPACTION FORCE, CROSS THREADING) LEADING TO THE FRACTURE OF THE TRIAL SPACER HANDLE SPINDLE TIP. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    (B)(4): SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DHR REVIEW ¿ DHR 389.151 LOT 7212998 RELEASED 3/26/13. AVALIGN TECHNOLOGIES ¿ NEMCOMED MANUFACTURED THE TRIAL SPACER HANDLE, P/N 389.151, AND LOT NUMBER 7212998. THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE INDICATES THE PARTS WERE MANUFACTURED TO P/N 389.151, AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION. NO NCRS WERE GENERATED FOR THIS LOT. 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 SUBJECT DEVICE WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. 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 THE TIP OF THE HANDLE FOR TRIAL SPACERS SHEARED OFF INTRAOPERATIVELY DURING AN L5-S1 SYNFIX-LR PLACEMENT AT LEVELS L5-S1. WHILE THE SURGEON WAS MALLETING IN THE SYNFIX-LR, 8 DEGREE , 26 MM DEPTH X 32 MM WIDTH IMPLANT TRIAL (PART NUMBER 03.802.016), THE TIP OF THE HANDLE FOR TRIAL SPACER (PART NUMBER 389.151) SHEARED OFF INTO THE TRIAL. A REMOVAL INSTRUMENT WAS IMMEDIATELY AVAILABLE AND TIP WAS EASILY RETRIEVED. THIS INCIDENT OCCURRED DURING THE TRIAL PORTION OF THE PROCEDURE AND THERE WAS NO IMPACT TO THE IMPLANT. THERE WAS NO SURGICAL DELAY OR PATIENT HARM REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446402 TRIAL SPACER HANDLE FORCEPS HTD SYNTHES MONUMENT 7212998

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR