BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR

    MDR report key: 8670945 · Received June 5, 2019

    Report

    Report Number
    8030965-2019-64922
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Report Date
    May 7, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MAX
    UDI-DI
    07611819414600
    PMA / PMN Number
    K151276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. 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

    IT WAS REPORTED THAT ON (B)(6) 2019, DURING SPINAL FUSION SURGERY, AFTER TRAILING FOR SIZE, TWO (2) APPLICATOR INNER SHAFT COULD NOT BE LOCKED INTO THE OUTER SHAFT AND KNOB. UPON A CLOSER EXAMINATION, AN OPERATING ROOM NURSE NOTED THAT THE TOP PART OF AN INSTRUMENT WAS MISSING. THE SMALL PART WAS NOT FOUND ON THE STERILIZATION TRAY. AS THE LOCKING FAILURE WAS NOTED ON AN INSTRUMENT TABLE AND THE DEVICE WAS NEVER HANDED TO THE SURGICAL FIELD, THERE WAS NO POSSIBILITY THAT THE PART COULD HAVE BEEN TRANSFERRED TO THE PATIENT. THE SET WAS EQUIPPED WITH TWO (2) APPLICATOR INNER SHAFT AND BOTH WERE FOUND TO BE DEFECTIVE. IT WAS CONCLUDED THAT THE DEVICES WERE PROBABLY DAMAGED DURING THE PREVIOUS SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 10 MINUTES SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. DURING THE FIRST YEARS OF INTRODUCTION OF THE T-PAL SYSTEM, SIMILAR DEFECTS HAVE BEEN FOUND IN THE GLOBAL MARKET. THE QUESTION RAISED BY THE SURGEON WAS, IF THESE TWO INSTRUMENTS COULD BE PART OF THE FIRST BATCHES THAT SHOWED SEVERAL BREAKAGES ON THE TOP FIXATION KNOB. CONCOMITANT DEVICE REPORTED: UNKNOWN OUTER SHAFT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN TRAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: PART: 03.812.003, LOT: 8830007. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 13 MAY 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. DEVICE INVESTIGATION: THE RETURNED APPLICATOR INNER SHAFT WAS EXAMINED, AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED. THE SPHERICAL END OF THE APPLICATOR INNER SHAFT IS BROKEN OFF; THE BROKEN OFF PART WAS NOT RETURNED FOR INVESTIGATION. THE INSTRUMENT PRESENTS SURFACE WEAR CONSISTENT WITH USE. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS INSTRUMENT WAS MANUFACTURED IN MAY 2014 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS. FURTHERMORE, THESE INSTRUMENTS ARE FUNCTION CHECKED WITH THE MATING PARTS PER 100% BEFORE THEY LEAVE THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND; THE DAMAGE OCCURRED IS DETERMINED TO BE POST PRODUCTION/ACCEPTANCE CRITERIA. THE ROOT CAUSE WAS IDENTIFIED DURING THE PERFORMED CQ EVALUATION AND THEREFORE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS ARE NOT REQUIRED. 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. AS EVERY T-PAL CASE IS EQUIPPED WITH TWO INNER SHAFTS, THE SURGERY SHOULD IN CASE OF A BREAKAGE BE CONTINUED WITHOUT DIFFICULTIES. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING SPINAL FUSION SURGERY, AFTER TRAILING FOR SIZE, TWO (2) APPLICATOR INNER SHAFT COULD NOT BE LOCKED ON AN UNKNOWN IMPLANT. UPON A CLOSER EXAMINATION, AN OPERATING ROOM NURSE NOTED THAT THE TOP PART OF AN INSTRUMENT WAS MISSING. THE SMALL PART WAS NOT FOUND ON THE STERILIZATION TRAY. AS THE LOCKING FAILURE WAS NOTED ON AN INSTRUMENT TABLE AND THE DEVICE WAS NEVER HANDED TO THE SURGICAL FIELD, THERE WAS NO POSSIBILITY THAT THE PART COULD HAVE BEEN TRANSFERRED TO THE PATIENT. THE SET WAS EQUIPPED WITH TWO (2) APPLICATOR INNER SHAFT AND BOTH WERE FOUND TO BE DEFECTIVE. IT WAS CONCLUDED THAT THE DEVICES WERE PROBABLY DAMAGED DURING THE PREVIOUS SURGERY. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. SURGICAL PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN IMPLANT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464830 T-PAL SPACER APPLICATOR INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX OBERDORF SYNTHES PRODUKTIONS GMBH 8830007 07611819414600

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - CAGE/SPACERS| UNK - INSERTION INSTRUMENTS| UNK - TRIALS