BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C8401, S ALEXIS O WND PROT/RET 5/BX

    MDR report key: 15723389 · Received November 3, 2022

    Report

    Report Number
    2027111-2022-00808
    Event Type
    Malfunction
    Date Received
    November 3, 2022
    Date of Event
    May 31, 2022
    Report Date
    November 23, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE DESCRIPTION OF THE EVENT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY USE ERROR. THE INDICATIONS IN THE INSTRUCTIONS FOR USE (IFU) STATES, "THE ALEXIS O 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." THE INDICATIONS IN THE INSTRUCTIONS FOR USE (IFU) ALSO STATES, "IN ADDITION, INDICATED SIZES MAY BE USED TO ACCESS THE THORACIC CAVITY OR OTHER SOFT TISSUE RETRACTION DURING CARDIAC AND GENERAL SURGICAL PROCEDURES." THE EVENT UNIT WAS USED IN A HIP ARTHROPLASTY PROCEDURE, WHICH INDICATES THAT THE DEVICE WAS USED OFF LABEL. IT IS LIKELY THAT THE SHEATH TEAR WAS CAUSED BY AN INSTRUMENT OR OBJECT (SUCH AS THE BONE RASP) THAT CAME INTO CONTACT WITH THE SHEATH, RESULTING IN A HOLE OR TEAR. AS THE SHEATH EXPERIENCES STRESSES DURING USE, IT IS POSSIBLE THAT THE HOLE OR TEAR PROPAGATED THROUGH THE SHEATH. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Additional Manufacturer Narrative · 0

    NO PRODUCT IS BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: HIP ARTHROPLASTY. EVENT DESCRIPTION: ALEXIS WAS USED AS A WOUND PROTECTOR DURING A HIP REPLACEMENT. WHILE INSERTING THE BONE RASP THE SHEET OF THE ALEXIS GOT DAMAGED. INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE IN PERSON 9NOV2022: NO ADDITIONAL INFORMATION AVAILABLE AS THE CUSTOMER MENTIONED IT IN PASSING AND DOES NOT REMEMBER THE DETAILS. INTERVENTION: NO ADDITIONAL INTERVENTION REQUIRED. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: HIP ARTHROPLASTY. EVENT DESCRIPTION: ALEXIS WAS USED AS A WOUND PROTECTOR DURING A HIP REPLACEMENT. WHILE INSERTING THE BONE RASP THE SHEET OF THE ALEXIS GOT DAMAGED. INTERVENTION: NO ADDITIONAL INTERVENTION REQUIRED. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509707 C8401, S ALEXIS O WND PROT/RET 5/BX RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL KGW APPLIED MEDICAL RESOURCES C8401 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BONE RASP