BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C8301, S ALEXIS WND PROT/RET 5/BX

    MDR report key: 11803246 · Received May 10, 2021

    Report

    Report Number
    2027111-2021-00485
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 27, 2021
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    UDI-DI
    00607915117207
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. HOWEVER, A PHOTOGRAPH OF THE EVENT UNIT CONFIRMED THAT THE SHEATH WAS TORN. BASED ON THE DESCRIPTION OF THE EVENT AND THE PHOTOGRAPH OF THE EVENT UNIT, IT IS LIKELY THAT THE SHEATH TEAR WAS CAUSED BY AN INSTRUMENT THAT CAME INTO CONTACT WITH THE SHEATH DURING THE PROCEDURE. THE EVENT UNIT WAS USED IN A TOTAL HIP ARTHROPLASTY PROCEDURE, WHICH INDICATES THAT THE DEVICE WAS USED OFF LABEL. PER THE INSTRUCTIONS FOR USE (IFU), "THE ALEXIS WOUND PROTECTOR/RETRACTOR IS A DEVICE THAT ALLOWS THE SURGEON TO ACCESS THE ABDOMINAL CAVITY THROUGH AN ATRAUMATICALLY RETRACTED WOUND, PROVIDING MAXIMUM EXPOSURE WITH MINIMUM INCISION SIZE AND ALSO INDICATED SIZES MAY BE USED TO ACCESS THE THORACIC CAVITY OR OTHER SOFT TISSUE RETRACTION DURING CARDIAC AND GENERAL SURGICAL PROCEDURES."

    Description of Event or Problem · 0

    NAME OF PROCEDURE PERFORMED: THA HOSPITAL: [NAME ] "WHEN ALEXIS WAS USED ON THE LEFT THA AND [NAME ] REMOVED ALEXIS AFTER THA TREATMENT, THE SLEEVE TEAR AND THE OUTER RING AND INNER RING WERE SEPARATED. AFTER THAT, THE INNER RING WAS REMOVED USING A TETHER. SURGEON CHECKED IF THERE WERE ANY REMAINING PIECES OF SLEEVE IN THE WOUND, AND THEN THE WOUND WAS CLOSED AND THE SURGERY WAS COMPLETED." PHOTOS OF THE DEVICE HAVE BEEN PROVIDED. NO PRODUCT RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 21APR2021 FROM [NAME]: METAL RETRACTORS, DRILLS, AND BONE CHISELS WERE USED THROUGH THE DEVICE. THE METAL RETRACTORS WAS USED FOR THE EXCLUSION OF MUSCLES AND TISSUES. THE DRILL WAS USED FOR BONE TRIMMING AND IMPLANT CONNECTION. THE BONE CHISEL WAS USED FOR TRIMMING BONES. ALL PIECES OF THE PRODUCT WAS REMOVED. THE PRODUCT WAS DISPOSED OF AFTER THE CASE AS IT WAS CONTAMINATED BY BLOOD. PATIENT STATUS: NO PATIENT INJURY TYPE OF INTERVENTION: DEVICE WAS REMOVED AND PATIENT WAS INSPECTED FOR PIECES OF THE PRODUCT. WOUND WAS THEN CLOSED AND SURGERY COMPLETED.

    Additional Manufacturer Narrative · 1

    EVENT UNIT WILL NOT RETURN TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    NAME OF PROCEDURE PERFORMED: THA. HOSPITAL: [NAME], "WHEN ALEXIS WAS USED ON THE LEFT THA AND [NAME ] REMOVED ALEXIS AFTER THA TREATMENT, THE SLEEVE TEAR AND THE OUTER RING AND INNER RING WERE SEPARATED. AFTER THAT, THE INNER RING WAS REMOVED USING A TETHER. SURGEON CHECKED IF THERE WERE ANY REMAINING PIECES OF SLEEVE IN THE WOUND, AND THEN THE WOUND WAS CLOSED AND THE SURGERY WAS COMPLETED." PHOTOS OF THE DEVICE HAVE BEEN PROVIDED. NO PRODUCT RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 21APR2021 FROM [NAME]: METAL RETRACTORS, DRILLS, AND BONE CHISELS WERE USED THROUGH THE DEVICE. THE METAL RETRACTORS WAS USED FOR THE EXCLUSION OF MUSCLES AND TISSUES. THE DRILL WAS USED FOR BONE TRIMMING AND IMPLANT CONNECTION. THE BONE CHISEL WAS USED FOR TRIMMING BONES. ALL PIECES OF THE PRODUCT WAS REMOVED. THE PRODUCT WAS DISPOSED OF AFTER THE CASE AS IT WAS CONTAMINATED BY BLOOD. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: DEVICE WAS REMOVED AND PATIENT WAS INSPECTED FOR PIECES OF THE PRODUCT. WOUND WAS THEN CLOSED AND SURGERY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697943 C8301, S ALEXIS WND PROT/RET 5/BX RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL KGW APPLIED MEDICAL RESOURCES C8301 1392024 00607915117207

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE CHISELS| DRILLS| METAL RETRACTORS