BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO-SP-1/2X1/2"-STRL 20/CS

    MDR report key: 21193130 · Received January 20, 2025

    Report

    Report Number
    1060680-2025-00004
    Event Type
    Malfunction
    Date Received
    January 20, 2025
    Date of Event
    January 7, 2025
    Report Date
    April 24, 2025
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    EFQ
    UDI-DI
    00749756037242
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "RADIOPAQUE STRINGS ARE FALLING OFF." DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS UNAVAILABLE FOR RETURN. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "RADIOPAQUE STRINGS ARE FALLING OFF." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS UNAVAILABLE FOR RETURN. INFORMATION WAS CORRECTED FOR PRODUCT CODE TO BE EFQ AND FOR THE 510K TO BE K791871 AS THESE WERE INPUT INCORRECTLY ON THE INITIAL REPORT. DEROYAL INDUSTRIES, INC. REVIEWED WORK ORDER FOR 759 CASES OF PRODUCT AND FOUND NO ISSUES. A REVIEW OF ANY CORRECTIVE AND PREVENTIVE ACTIONS (CAPAS) WAS CONDUCTED AND NO APPLICABLE CAPAS WERE FOUND. AN INVENTORY CHECK WAS NOT ABLE TO BE PERFORMED AS THERE WAS NO INVENTORY ON HAND. THIS IS ALSO A PURCHASED PRODUCT THAT DEROYAL INDUSTRIES JUST DISTRIBUTES SO NO RISK ANALYSIS WAS REVIEWED BY DEROYAL. A COMPLAINT TO SALES RATIO WAS CONDUCTED FROM JANUARY 2023 TO JANUARY 2025 AND WAS FOUND TO BE (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE MANUFACTURER AND RETURNED. THE SUPPLIER CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW, INTERVIEWS WITH STAFF AND SUPERVISORS, AND A REVIEW OF MANUFACTURING PROCESSES. ROOT CAUSE: DURING THE INVESTIGATION, IT WAS DETERMINED THAT THE OPERATOR DID NOT CONDUCT PERIODIC INSPECTIONS OF THE WELDING PROCESS AS REQUIRED. IT WAS FOUND THAT THERE WAS A VARIANCE IN WELD DUE TO VARIANCE IN MATERIAL AND HORN TYPE (WELDER TIPS) USED DURING THE WELDING PROCESS. THE INVESTIGATION ALSO REVEALED THAT WHILE THE RISK OF X-RAY DETACHMENT IS NORMALLY A RISK, THERE IS A POTENTIALLY GREATER RISK THAT WAS INTRODUCED WITH THE RECENT ADDITION OF NEW EMPLOYEES TO THE X-RAY WELDING PROCESS THAT COULD RESULT FROM A LACK OF EXPERIENCE WITH THE MATERIAL, PROCESS, AND PRODUCT OF NEW HIRES. CORRECTIVE AND PREVENTIVE ACTIONS: A RISK ASSESSMENT WAS CONDUCTED TO IDENTIFY POTENTIAL RISKS ASSOCIATED WITH UNDECTED X-RAY WELD DEFECTS IN FINISHED GOOD PRODUCTS. A NEW FORM WAS CREATED TO REGISTER THE X-RAY WELDING PROCESS VERIFICATION EVERY 30 MINUTES DURING THE MANUFACTURING PROCESS AND TO REGISTER THE VERIFICATION OF THE HORN ANVIL DISTANCE USING THE FEELER GAUGE. PRODUCTION OPERATORS WERE TRAINED IN THE USE OF THE FEELER GAUGE AND WERE RETRAINED TO REINFORCE THE CRITICALITY OF THE PRODUCT WE ARE MANUFACTURING AND TO MONITOR/CHECK FOR PROPER X-RAY ATTACHMENT. MONITORING X-RAY ATTACHMENT SHALL BE DOCUMENTED IN THE NEW FORM WITH EVIDENCE OF VERIFICATION OF THE HORN ANVIL DISTANCE AND TO REGISTER THE VERIFICATION OF THE WELDING EVERY 30 MINUTES DURING THE WELDING PROCESS. SUBSEQUENTLY, NEW HORN TIPS WERE PURCHASED TO REPLACE THE CURRENT HORNS. THESE NEW HORNS PROVIDE MORE STABILITY TO THE WELD PROCESS; IF THERE IS ANY VARIANCE IN THE MATERIAL, THE WIDER HORNS SHALL KEEP THE MATERIAL FLAT AND STABLE. LASTLY, THE IN-PROCESS AND FINISHED GOOD INSPECTION PROCESS TO IMPROVE THE METHODS/FREQUENCY USED TO MONITOR X-RAY WELDS. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "RADIOPAQUE STRINGS ARE FALLING OFF".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722085 NEURO-SP-1/2X1/2"-STRL 20/CS GAUZE/SPONGE, INTERNAL EFQ MEDSORB DOMINICANA, S.A. 30-054 24102694 00749756037242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown