BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMNIOTIC MEMBRANE PERFORATOR

    MDR report key: 22629883 · Received July 28, 2025

    Report

    Report Number
    1060680-2025-00045
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    July 23, 2025
    Report Date
    September 22, 2025
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    HGE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "SMALL HOOK BROKE OFF WHILE ATTEMPTING TO AROM PATIENT WITH 2 DIFFERENT AMNIHOOKS. TESTED AT DESK USING GLOVES AND SMALL HOOK ALSO BROKE." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE(S) BUT IT HAS YET TO BE RETURNED. THE 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, "SMALL HOOK BROKE OFF WHILE ATTEMPTING TO AROM PATIENT WITH 2 DIFFERENT AMNIHOOKS. TESTED AT DESK USING GLOVES AND SMALL HOOK ALSO BROKE." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE(S) BUT, THEY WERE NOT RECEIVED. FOLLOW UP EMAILS WERE SENT ASKING FOR SAMPLES OR PICTURES TO BE SENT OF THE DEVICE, HOWEVER THE DEVICE NOR ANY PHOTOS WERE RECEIVED. THE DEVICE HISTORY RECORD (DHR) FOR THE AMNIOTIC MEMBRANE PERFORATOR WITH LOT NUMBER 618685679 WAS REVIEWED. NO DISCREPANCIES WERE FOUND WITHIN THE DHR. CERTIFICATES OF ANALYSIS WERE ALSO REVIEWED FOR THE MATERIAL USED TO MOLD THE PERFORATOR AND FOUND TO BE WITHIN THE ACCEPTED RANGES LISTED. AN INVENTORY CHECK WAS PERFORMED ON 32 CASES OF PRODUCTS AND NO PARTS WERE FOUND TO HAVE ANY DAMAGED OR BROKEN HOOK AREAS. SEVERAL SAMPLE PARTS WERE PULLED FROM THE DISTRIBUTION CENTER FROM LOTS 60822479 AND 62207701. EACH OF THE PARTS WERE FOUND TO BE VISUALLY CONFORMING. PARTS WERE ALSO CONFIRMED TO PERFORATE A PLASTIC BAG AS WELL AS A GLOVE WITHOUT THE HOOK AREA BREAKING. NO MANUFACTURING DEFECTS COULD BE IDENTIFIED. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE (B)(4). ROOT CAUSE: BECAUSE THE SAMPLE NOR PHOTOS WERE RETURNED AND NO ISSUES WERE IDENTIFIED WITH THE MANUFACTURING PROCESS IN THE INVESTIGATION, THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE THE ROOT CAUSE WAS UNABLE TO BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "THE ITEM BROKE WHILE IT WAS IN USE AND IT WAS WITH 2 LOT #S. NO INJURY REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651370 AMNIOTIC MEMBRANE PERFORATOR AMNIOTOME HGE DEROYAL INDUSTRIES, INC. 72-7100 62091999

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown