BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL KNEE PACK A & B

    MDR report key: 9377516 · Received November 26, 2019

    Report

    Report Number
    3005011024-2019-00015
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    October 28, 2019
    Report Date
    February 25, 2020
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LRO
    UDI-DI
    00749756653268
    PMA / PMN Number
    K842648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: THE SPONGE IS SUPPLIED TO DEROYAL BY US MEDCO. THEREFORE, A SUPPLIER CORRECTIVE ACTION REPORT (SCAR) WAS ISSUED TO US MEDCO. IN ITS RESPONSE, THE VENDOR STATED THE ORIGIN OF THE FIBER IS UNKNOWN. THE FIBER IS NOT 100 PERCENT COTTON AND, THEREFORE, DOES NOT BELONG TO THE LAP SPONGE, WHICH IS MADE OF COTTON. IN NO OTHER STAGES OF MANUFACTURING IS ANOTHER TYPE OF FIBER HANDLED, SO IT IS POSSIBLE THE FIBER FELL FROM STAFF CLOTHING, CAUSING THE CONTAMINATED PRODUCT. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, THE VENDOR STATED THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED: A) DRESS CHECKS ARE REQUIRED FOR ALL PERSONNEL BEFORE ENTERING THE TO VERIFY THERE IS NO POSSIBILITY OF BRINGING FIBERS INTO THE WORK AREA; B) A SHAKE IS PERFORMED ON THE LAP SPONGE TO REMOVE FIBERS OR THREADS THAT MAY BE IN THE PRODUCT; C) THE VACUUM SYSTEM WAS IMPROVED TO DECREASE OR REMOVE PARTICLES ON THE PRODUCT; D) AIR FILTERS ARE CLEANED EVERY HOUR TO AVOID OBSTRUCTIONS; E) PRESSURE GAUGES WERE PLACED TO ENSURE AIR UNIFORMITY AT THE OUTLETS OF THE VACUUM SYSTEM; F) A FORM WAS IMPLEMENTED TO KEEP AN AIR PRESSURE RECORD AT EACH OUTLET TO ENSURE IT IS WORKING PROPERLY; AND G) THE MANUFACTURING PROCEDURE WAS UPDATED TO INCLUDE THE IMPLEMENTED CHANGES. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED INDICATING THAT, DURING A BILATERAL TOTAL KNEE PROCEDURE, FIBERS WERE NOTICED IN BOTH KNEES. THESE FIBERS APPEARED TO COME FROM THE LAP SPONGES PACKAGED IN THE TOTAL KNEE TRAY (PART: 89-5796, LOT: 50635750). A SAMPLE WAS RETURNED NOVEMBER 1 FOR REVIEW. THE SAMPLE CONSISTED OF REPORTED FIBERS INSIDE OF SPECIMEN CUPS AND ONE LAP SPONGE. THE SAMPLE WAS SHIPPED FOR DECONTAMINATION AND PHOTOS WERE SENT NOVEMBER 1 TO THE SUPPLIER, US MEDCO. THE WORK ORDER WAS REVIEWED FOR POSSIBLE DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO DISCREPANCIES WERE IDENTIFIED. THE BILL OF MATERIALS FOR THE FINISHED GOOD WAS REVIEWED, AND THE AFFECTED RAW MATERIAL WAS IDENTIFIED AS 1818-1, AN 18X18 LAP SPONGE CONTAINED WITHIN THE CONVENIENCE KIT. THIS RAW MATERIAL IS SUPPLIED TO DEROYAL BY US MEDCO. THE 2017-2019 SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. A SIMILAR COMPLAINT WAS IDENTIFIED, AND A SCAR WAS ISSUED TO US MEDCO. A RESPONSE WAS RECEIVED NOVEMBER 27, 2019 AND ACCEPTED BY DEROYAL PERSONNEL. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    DURING A BILATERAL TOTAL KNEE REPLACEMENT PROCEDURE, A FIBER WAS NOTICED IN BOTH KNEES. THE FIBER APPEARED TO COME FROM THE LAP SPONGES CONTAINED IN THE CONVENIENCE KIT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THAT, DURING A BILATERAL TOTAL KNEE PROCEDURE, FIBERS WERE NOTICED IN BOTH KNEES. THESE FIBERS APPEARED TO COME FROM THE LAP SPONGES PACKAGED IN THE TOTAL KNEE TRAY (PART 89-5796, LOT 50635750). A SAMPLE WAS RETURNED NOVEMBER 1 FOR REVIEW. THE SAMPLE CONSISTED OF REPORTED FIBERS INSIDE OF SPECIMEN CUPS AND ONE LAP SPONGE. THE SAMPLE WAS SHIPPED FOR DECONTAMINATION AND PHOTOS WERE SENT NOVEMBER 1 TO THE SUPPLIER, US MEDCO. THE WORK ORDER WAS REVIEWED FOR POSSIBLE DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO DISCREPANCIES WERE IDENTIFIED. THE BILL OF MATERIALS FOR THE FINISHED GOOD WAS REVIEWED, AND THE AFFECTED RAW MATERIAL WAS IDENTIFIED AS 1818-1, AN 18X18 LAP SPONGE CONTAINED WITHIN THE CONVENIENCE KIT. THIS RAW MATERIAL IS SUPPLIED TO DEROYAL BY US MEDCO. THE 2017-2019 SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. A SIMILAR COMPLAINT WAS IDENTIFIED, AND A SCAR WAS ISSUED TO US MEDCO. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    DURING A BILATERAL TOTAL KNEE REPLACEMENT PROCEDURE, A FIBER WAS NOTICED IN BOTH KNEES. THE FIBER APPEARED TO COME FROM THE LAP SPONGES CONTAINED IN THE CONVENIENCE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169313 TOTAL KNEE PACK A & B GENERAL SURGERY TRAY LRO DEROYAL INDUSTRIES, INC. 89-5796 50635750 00749756653268

    Patients

    Seq Age Sex Outcome Treatment
    1