BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR INNER SHAFT

    MDR report key: 9720773 · Received February 18, 2020

    Report

    Report Number
    8030965-2020-01200
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Report Date
    January 28, 2020
    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. PART: 03.812.003, LOT: 8922277, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: JUNE 2, 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE CAP AT THE END OF THE SHAFT IS BROKEN OFF AS COMPLAINED. THE CAP WAS NOT RETURNED FOR EVALUATION. IN GENERAL, THE INNER SHAFT IS IN A USED CONDITION, THE EDGES AT THE GROOVE ARE SLIGHTLY DEFORMED. AT THE FORK ARE CLEARLY VISIBLE SIGNS OF OFTEN AND INTENSE USE. DIMENSIONAL INSPECTION: DIAMETER AT FRACTURE FACE PASS DRAWING SPECIFICATION REVIEW: DRAWING WAS REVIEWED TO VERIFY THE RELEVANT DIMENSION, MATERIAL AND HARDNESS OF THE CLAMP SHAFT, SUB COMPONENT 60051594. THIS SUB-COMPONENT IS NOT LOT TRACKED. THEREFORE THE LAST THREE POTENTIAL WORK ORDERS THAT WERE PRODUCED PRIOR TO LOT 8922277 WERE REVIEWED. THE REVIEW HAS SHOWN THAT THE CORRECT MATERIAL WAS USED AND THAT THE HARDNESS WAS WITHIN THE SPECIFICATION. INVESTIGATION CONCLUSION: THE RECEIVED CONDITION OF THE DEVICE IS CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. DURING THE PERFORMED EVALUATION, NO MANUFACTURING RELATED ISSUE COULD BE IDENTIFIED. BASED ON THE PROVIDED INFORMATION, THE EXACT CAUSE OF THIS BREAKAGE CANNOT BE DEFINED. IN GENERAL, IT CAN BE STATED THAT 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. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    THE DEVICE HAS BEEN 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. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) SPACER APPLICATOR INNER SHAFT IN QUESTION WAS USED FOR AN UNKNOWN PROCEDURE WITHOUT AN ISSUE.ON (B)(6) 2020 THE SAME T-PAL SPACER INNER SHAFT WAS USED FOR A TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF) TO TREAT LUMBER VERTEBRAE HERNIATED DISK, HOWEVER DURING THE PROCEDURE THE NURSE WAS NOT ABLE TO HOLD A CAGE WITH THE INNER SHAFT. IT WAS FOUND THAT THE STOPPER HAD BEEN MISSING. THE BACK UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY REPORTED. PATIENT OUTCOME WAS REPORTED AS STABLE. IT WAS FURTHER REPORTED THAT THE INNER SHAFT IN QUESTION WAS NOT DAMAGED DURING THE (B)(6) 2020 PROCEDURE. IT WAS CLEANSED AND STERILIZED POSTOPERATIVE; HOWEVER THE PHOTO, TAKEN PRIOR TO THE (B)(6) PROCEDURE, SHOWED THE BREAKAGE. CONCOMITANT DEVICE REPORTED: APPLICATOR OUTER SHAFT (PART # 03.812.001, LOT # UNKNOWN, QUANTITY # 1); APPLICATOR KNOB (PART # 03.812.004, LOT # UNKNOWN, QUANTITY # 1); UNKNOWN CAGE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE (1) T-PAL SPACER APPLICATOR INNER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182665 T-PAL SPACER APPLICATOR INNER SHAFT INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX OBERDORF SYNTHES PRODUKTIONS GMBH 8922277 07611819414600

    Patients

    Seq Age Sex Outcome Treatment
    1 APPLICAT OUT SHAFT| APPLICATOR KNOB| UNK - CAGE/SPACERS