BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR HANDLE

    MDR report key: 8957757 · Received September 3, 2019

    Report

    Report Number
    2939274-2019-60288
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Report Date
    August 6, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    MAX
    UDI-DI
    10705034727783
    PMA / PMN Number
    K151276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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. H3, H4, H6: INVESTIGATION SUMMARY VISUAL INSPECTION: THE T-PAL SPACER APPLICATOR HANDLE (PART # 03.812.001 LOT # 8093408) WAS RECEIVED AT US CUSTOMER QUALITY. THE DEVICE HAS LIGHT SURFACE SCRATCHES ALONG THE SHAFT AND THE DISTAL TEETH OF THE DEVICE HAVE BROKEN OFF. IT APPEARS THAT THE DEVICE WAS ALTERED POST-MANUFACTURING AS THE FRACTURE SITE IS COMPLETELY SMOOTH. THERE ARE NO EVIDENT SHEAR MARKS. MAGNIFICATION HIGHLIGHTS THAT THE SURFACE WAS ALTERED-POST MANUFACTURING AS EVIDENCED BY ITS UNIFORM SURFACE. THE DEVICE IS MISSING THE APPLICATOR KNOB. THE RECEIVED CONDITION IS CONSISTENT WITH THE COMPLAINT CONDITION THUS THE COMPLAINT IS CONFIRMED. DEVICE FAILURE/DEFECT IDENTIFIED: TEETH HAVE BROKEN OFF, DEVICE WAS ALTERED, APPLICATOR KNOB WAS MISSING. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE AND MISSING COMPONENTS. MANUFACTURING RECORD EVALUATION: THE RECEIVED T-PAL SPACER APPLICATOR HANDLE (PART # 03.812.001 LOT # 8093408) WAS MANUFACTURED AT THE (B)(6) SITE ON OCT 26, 2012. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE T-PAL SPACER APPLICATOR HANDLE (PART # 03.812.001 LOT # 8093408) AS THE DISTAL TEETH OF THE DEVICE HAS BROKEN OFF. AS MENTIONED IN THE VISUAL INSPECTION, MAGNIFICATION SHOWS THAT THE SURFACE WHERE THE BREAKAGE WOULD HAVE OCCURRED WAS SMOOTH AND UNIFORM WHICH INDICATES THAT THE DEVICE WAS ALTERED POST-MANUFACTURING. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES DURING USE WHICH LEAD TO ITS BREAKAGE. IT IS POSSIBLE THAT THE USER OF THE DEVICE SMOOTHED DOWN THE SURFACE AFTER THE BREAKAGE, OR THE USER INTENTIONALLY ADULTERATED THE DEVICE TO REMOVE THE TEETH AND SMOOTHED THE SURFACE FOR AN UNKNOWN REASON. BASED ON THE DESIGNED USE OF THIS PRODUCT, IF THE DEVICE WAS USED AFTER BREAKAGE, NORMAL WEAR/STERILIZATION WOULD NOT YIELD A UNIFORM SMOOTH SURFACE, THE DISTAL TIP WOULD HAVE HAD TO BE MACHINED/FILED TO THE OBSERVED SMOOTHNESS. THE DEVICE WAS ALSO FOUND TO BE MISSING THE APPLICATOR KNOB. THE APPLICATOR KNOB MAY HAVE BEEN MISPLACED DURING STERILIZATION, AS THE DEVICE REQUIRES TO BE DISASSEMBLED PRIOR TO STERILIZATION. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT PART: 03.812.001 LOT: 8093408 MANUFACTURING SITE: (B)(6) RELEASE TO WAREHOUSE DATE: OCT 26, 2012 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. 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

    LIBERTAS: IT WAS REPORTED THAT ON (B)(6) 2019, THE APPLICATOR OUTER SHAFT WAS FOUND BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) T-PAL SPACER APPLICATOR HANDLE THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748844 T-PAL SPACER APPLICATOR HANDLE INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.812.001 8093408 10705034727783

    Patients

    Seq Age Sex Outcome Treatment
    1