BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VBS W/BALLOON SM

    MDR report key: 12414124 · Received September 2, 2021

    Report

    Report Number
    8030965-2021-07425
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    August 3, 2021
    Report Date
    August 3, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    UDI-DI
    07611819471849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT VBS W/BALLOON SM THE BALLOON WAS PUNCTURED, AND NO OTHER ISSUES WERE IDENTIFIED. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE POST MANUFACTURING DAMAGE. THE OBSERVED CONDITION OF VBS W/BALLOON SM IN THE DEVICE WAS CONSISTENT WITH 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 FOR VBS W/BALLOON SM. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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. DEVICE HISTORY LOT ==> PART # 09.804.600S SYNTHES LOT # J002434 SUPPLIER LOT # 82213553 RELEASE TO WAREHOUSE DATE: 15FEB2021 EXPIRATION DATE: 01FEB2024 SUPPLIER: (B)(4) THIS NON-CONFORMANCE IS NOT RELEVANT TO THE ADVERSE IMPACT IN THE PRODUCT DUE TO DATA PARAMETER NOT RECORDED, SINCE THE PROCESS HAVE INSPECTION CONTROLS IN PLACE THAT ENSURE THAT THE PRODUCT MET THE SPECIFICATION, ALSO THE LINE CLEARANCE RECORDS AND EQUIPMENT RECORDS SUPPORTS THAT THE OPERATION PARAMETER WAS EXECUTED CORRECTLY. 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

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J REPRESENTATIVE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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, THE PATIENT UNDERWENT FOR A PERCUTANEOUS VERTEBROPLASTY SURGERY. DURING THE SURGERY, WHEN THE TRIAL BALLOON WAS INFLATED UP TO 14 ATM, THE BALLOON BROKE. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1)1.5MM DRILL BIT/QC/110MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310244 VBS W/BALLOON SM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SYNTHES GMBH J002434 07611819471849

    Patients

    Seq Age Sex Outcome Treatment
    1