BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR HANDLE

    MDR report key: 11975692 · Received June 10, 2021

    Report

    Report Number
    8030965-2021-04770
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 3, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    MAX
    UDI-DI
    07611819405813
    PMA / PMN Number
    K151276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. H3, H4, H6: PART # 03.812.001, LOT # L042558, RELEASE TO WAREHOUSE DATE: NOVEMBER 10, 2016 , MANUFACTURER: HAGENDORF, SUPPLIER: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: APPLICAT OUT SHAFT (PART# 03.812.001, LOT# L042558, QTY# 1) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE DEVICE LOOKS GOOD WITHOUT ANY PHYSICAL DAMAGE. THE SURFACE OF THE DEVICE SHOWS NORMAL WEAR CONSISTENT WITH THE DEVICE USE WHICH WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. FUNCTIONAL TEST: FUNCTIONAL TESTING OF THE RECEIVED DEVICE WAS PERFORMED AT CQ. OUTER SHAFT WAS ASSEMBLED AND DISASSEMBLED WITH APPLICATOR INNER SHAFT AS INTENDED WITHOUT ANY ISSUES. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE(S)? NO DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DOCUMENT(S) WAS REVIEWED: APPLICATOR HANDLE CPL: CURRENT AND MANUFACTURED REVISIONS APPLICATOR INNER SHAFT CPL: CURRENT AND MANUFACTURED REVISIONS NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. COMPLAINT CONFIRMED? NO . INVESTIGATION CONCLUSION: THE COMPLAINT CANNOT BE CONFIRMED FOR APPLICAT OUT SHAFT AS NO FUNCTIONAL ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED PROBLEM. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED UPON THESE RESULTS, NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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) 2021, AT THE DISTAL TIP THERE WERE MARKINGS THAT MADE IT DIFFICULT TO INSERT THE INNER SHAFT AND TRIAL IMPLANT. THE ALIGNMENT GUIDE HAD A DEFECT IN THE DISTAL PART AND THE CEMENT CANNULA WOULD NOT GO THROUGH IT. THE ISSUE WAS IDENTIFIED DURING PRE-OP. ANOTHER PRODUCT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO REPORTED SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) T-PAL SPACER APPLICATOR HANDLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874057 T-PAL SPACER APPLICATOR HANDLE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX SYNTHES GMBH L042558 07611819405813

    Patients

    Seq Age Sex Outcome Treatment
    1 APPLICAT OUT SHAFT| APPLICAT OUT SHAFT| APPLICAT OUT SHAFT| APPLICATOR INNER SHAFT| APPLICATOR INNER SHAFT| UNK - INSERTION INSTRUMENTS| APPLICAT OUT SHAFT| UNK - INSERTION INSTRUMENTS