BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR INNER SHAFT

    MDR report key: 7971757 · Received October 16, 2018

    Report

    Report Number
    8030965-2018-57382
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    October 2, 2018
    Report Date
    October 3, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MAX
    UDI-DI
    07611819414600
    PMA / PMN Number
    K151276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE EVALUATED BY MFR: PART: 03.812.003; LOT: 8830007; MANUFACTURING LOCATION: HAEGENDORF; RELEASE TO WAREHOUSE DATE: MAY 13, 2014. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. ONLY TOP LEVEL OF THE DEVICE HISTORY RECORD REVIEWED AS SUB-COMPONENTS ARE NOT LOT TRACKED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SELECTION: INVESTIGATION SITE: CQ ZUCHWIL; SELECTED FLOW: 5. BROKEN. VISUAL INSPECTION: THE T-PAL INSTRUMENT IS IN A USED CONDITION WITH SLIGHT SCRATCHES. THE KNOB AT THE END OF THE INNER SHAFT IS BROKEN OFF. DIMENSIONAL INSPECTION: BECAUSE OF THE DAMAGES, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED TO PRINT SPECIFICATIONS. DRAWING/SPECIFICATION REVIEW: THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE, THEREFORE NO DRAWING/SPECIFICATION REVIEW IS NEEDED. MATERIAL REVIEW: THE USED MATERIAL FOR SUB-COMPONENT 60051594 WAS STAINLESS STEEL 1.4028 AS REQUIRED AND THE MEASURED HARNESS WAS WITH 50-52 HRC WITHIN THE SPECIFICATION OF 48-52 HRC. SUMMARY: THE RECEIVED CONDITION OF THE DEVICE IS CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. THE T-PAL APPLICATOR INSTRUMENTS ARE DESIGNED AND PRODUCED TO WITHSTAND NORMAL FORCES DURING A SURGERY. AS EVERY SURGEON HAS A DIFFERENT TACTILE FEELING/FEEDBACK AND FORCES CAN VARY, THE INNER SHAFT HAS A PREDETERMINED BREAKING POINT ON THE PROXIMAL END. WHENEVER A CERTAIN AXIAL FORCE IS BEING ACHIEVED THE INSTRUMENT SHOULD BREAK RATHER ON THE PROXIMAL END THAN ON THE DISTAL END. THIS ALLOWS THE SURGEON TO DISMANTLE THE INSTRUMENT AND REMOVE IT SAFELY WITH NO PATIENT CONTACT TO ANY BROKEN PARTS. THEREFORE, WE CAN CONFIRM THE VISIBLE DAMAGES ARE NOT FROM ANY MANUFACTURING NON-CONFORMITY. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 · 0

    CONCOMITANT DEVICES: CAGE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), INSERTER (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) TO FIX L5/S DUE TO A LUMBAR SPINAL CANAL STENOSIS ON (B)(6) 2018, THE T-PAL SPACER APPLICATOR INNER SHAFT WAS BROKEN. THE ISSUE HAPPENED WHEN THE SURGEON REMOVED THE INSERTER FROM THE CAGE THAT WAS INSERTED TO THE PATIENT'S BODY. ALL BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT'S BODY. AN ALTERNATIVE T-PAL SPACER APPLICATOR INNER SHAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY REPORTED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN CAGE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812902 T-PAL SPACER APPLICATOR INNER SHAFT INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX OBERDORF SYNTHES PRODUKTIONS GMBH 8830007 07611819414600

    Patients

    Seq Age Sex Outcome Treatment
    1