BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFLATE BALLOON/MEDIUM- STERILE

    MDR report key: 19609865 · Received June 25, 2024

    Report

    Report Number
    8030965-2024-07886
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    May 29, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    PMA / PMN Number
    K130146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. D2B.: ADDITIONAL PRO-CODE: NDN. E3: REPORTER IS A J&J SALES REPRESENTATIVE. H6: THE SUBJECT 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.

    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 INVESTIGATION SUMMARY 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 MED HAD SIGNS OF TEARING OFF AND BREAKAGE ALONG THE SURFACE OF THE BALLOON. THE PROTECTION SLEEVE WAS NOT RETURNED. A DIMENSIONAL INSPECTION AND A FUNCTIONAL TEST FOR THE SYNFLATE VERTEBRAL BALLOON MED WERE UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. SINCE THE DEVICE WAS RETURNED DEFLATED AND DAMAGED, THE COMPLAINT CONDITION OF NOT BEING ABLE TO INFLATE/DEFLATE WAS NOT ABLE TO BE REPLICATED. HOWEVER, THIS IS MOST LIKELY DUE TO THE BREAKAGE CONDITION OF THE BALLOON. THE COMPLAINT WAS REVIEWED WITH THE SUPPLIER AND IT WAS CONFIRMED THAT ALL PARTS PASS A 100% LEAK TEST AND ALL LOTS HAVE A SAMPLE BURST TEST PERFORMED AS PART OF LOT ACCEPTANCE. AS PART OF THE INVESTIGATION, THE SUPPLIER ALSO PERFORMED A BURST TEST ON 2 NEW PRODUCTION DEVICES AND BOTH BURST ABOVE THE REQUIRED 30 ATMOSPHERES. A VISUAL EXAMINATION OF THE BURST TEST SAMPLES CONFIRMED THE CONDITION OF THE BALLOONS WERE CONSISTENT WITH THE COMPLAINT DEVICES. THE SYNFLATE VERTEBRAL BALLOON SURGICAL TECHNIQUE WAS REVIEWED; STATES TO STOP BALLOON EXPANSION IF ANY OF THE FOLLOWING HAPPENS: ¿ THE DESIRED OUTCOME IS REACHED ¿ THE PRESSURE REACHES 30 ATM (440 PSI) ¿ THE MAXIMUM BALLOON VOLUME IS ACHIEVED ¿ 4.0 ML FOR THE SMALL BALLOON ¿ 5.0 ML FOR THE MEDIUM BALLOON ¿ 6.0 ML FOR THE LARGE BALLOON ¿ ANY PART OF THE INFLATED BALLOON LENGTH TOUCHES THE CORTICAL BONE THE SURGICAL TECHNIQUE GUIDE ALSO CONTAINS THE FOLLOWING PRECAUTIONS: - THE BALLOONS MAY LEAK IF THEY ARE FILLED BEYOND THEIR MAXIMUM VOLUME OR PRESSURE. - THE PERFORMANCE OF THE BALLOONS CATHETER MAY BE ADVERSELY AFFECTED IF IT COMES INTO CONTACT WITH BONE SPLINTERS, BONE CEMENT AND/OR SURGICAL INSTRUMENTS. THE SURGICAL TECHNIQUE GUIDE ALSO RECOMMENDS THE FOLLOWING: - TO PROCEED WITH INFLATION SLOWLY, STOPPING EVERY FEW SECONDS TO ALLOW THE BONE TO ADJUST TO THE PRESSURE/VOLUME CHANGES. - FOR BILATERAL PROCEDURES, INFLATE EACH BALLOON ALTERNATELY IN INCREMENTS THE FAILURES OBSERVED ON THE RETURNED DEVICES ARE CONSISTENT WITH FAILURE DUE TO OVER EXPANSION OR PRESSURIZATION. PER THE SURGICAL TECHNIQUE GUIDE, EXPANSION SHOULD BE DISCONTINUED AS THE MAXIMUM VOLUME HAD BEEN REACHED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SYNFLATE VERTEBRAL BALLOON MED WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DIMENSIONAL INSPECTION: N/A DEVICE HISTORY PART: 03.804.701S, SYNTHES LOT: 82283823, SUPPLIER LOT: 82283823, RELEASE TO WAREHOUSE DATE:19 JUL 2023, SUPPLIER: (B)(4). NO NCR'S GENERATED DURING PRODUCTION. 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 THIS WAS A PERCUTANEOUS VERTEBROPLASTY (FUSION COMBINED) FOR OSTEOPOROTIC VERTEBRAL FRACTURE ON (B)(6) 2024, WITH SYNFLATE. IN THE SURGERY, THE SURGEON PLACED THE BALLOON IN QUESTION INTO THE VERTEBRAL BODY AFTER NEGATIVE PRESSURE. SUBSEQUENTLY, THE DILATANT CAME OUT FROM THE TIP SLIGHTLY ABOVE THE CONNECTION BETWEEN THE INFLATION AND THE BALLOON, AND THE DILATANT COULD NOT BE DELIVERED INTO THE VERTEBRAL BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME AND NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SYNFLATE BALLOON/MEDIUM- STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481165 SYNFLATE BALLOON/MEDIUM- STERILE CEMENT, BONE, VERTEBROPLASTY NDN SYNTHES GMBH 82283823

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SYNFLATE VERTEBRAL BALLOON MED| SYNFLATE VERTEBRAL BALLOON MED