BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFLATE VERTEBRAL BALLOON SM

    MDR report key: 13996516 · Received April 4, 2022

    Report

    Report Number
    8030965-2022-02158
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 4, 2022
    Report Date
    April 4, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRX
    UDI-DI
    07611819525382
    PMA / PMN Number
    K130146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE: NDN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J SALES REPRESENTATIVE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    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. H10 ADDITIONAL NARRATIVE: D4. 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. E2; E3; H5.

    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. H10 ADDITIONAL NARRATIVE: H3, H6 INVESTIGATION SUMMARY THE PHOTO WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE FROM ATTACHMENT (SOURCE IMAGE). VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE SYNFLATE VERTEBRAL BALLOON SM (P/N: 03.804.700S, LOT: H888230) DOES NOT INFLATE PROPERLY, SINCE THE EXPANSION OF THE BALLOON IT IS INCOMPLETE, HENCE, THE ALLEGATION REPORTED CAN BE CONFIRMED. NO OTHER ISSUES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SYNFLATE VERTEBRAL BALLOON SM (P/N: 03.804.700S, LOT: H888230) DOES NOT INFLATE PROPERLY, SINCE THE EXPANSION OF THE BALLOON IT IS INCOMPLETE, THEREFORE, THE ALLEGATION REPORTED CAN BE CONFIRMED. NO OTHER ISSUES WERE OBSERVED. A FUNCTIONAL TEST WAS NOT PERFORMED ON THE COMPLAINT PIECE DUE TO LACK OF MATING DEVICES. A DIMENSIONAL INSPECTION WAS NOT PERFORMED FOR THE SYNFLATE VERTEBRAL BALLOON SM SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SYNFLATE VERTEBRAL BALLOON SM (P/N: 03.804.700S, LOT: H888230) WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT 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. DRAWING/SPECIFICATIONS REVIEWED? NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. H4 DEVICE HISTORY PART#: 03.804.700S LOT #: H888230 MANUFACTURING SITE: WERK SELZACH SUPPLIER: SYNTHES USA HQ, INC RELEASE TO WAREHOUSE DATE: 07 JAN 2020 EXPIRATION DATE: 01 JAN 2022. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT INTRAOPERATIVELY IT WAS NOTICED THAT THE BALLOON DOES NOT APPEAR TO DILATE EVENLY AROUND THE WIRE. ANOTHER BALLOON WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITHOUT ANY PATIENT IMPACT. THIS COMPLAINT INVOLVES ONE (1) DEVICE SYNFLATE VERTEBRAL BALLOON SM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83150 SYNFLATE VERTEBRAL BALLOON SM ARTHROSCOPE HRX SYNTHES GMBH H888230 07611819525382

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown