BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C8402, M ALEXIS O WND PROT/RET 5/BX

    MDR report key: 9468863 · Received December 13, 2019

    Report

    Report Number
    2027111-2019-00665
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    November 21, 2019
    Report Date
    February 21, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KWG
    UDI-DI
    00607915117269
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, TESTING WAS UNABLE TO BE PERFORMED AND THE COMPLAINANT¿S EXPERIENCE COULD NOT BE CONFIRMED. BASED ON THE EVENT DESCRIPTION, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY AN INSTRUMENT THAT CAME IN CONTACT WITH THE SHEATH DURING THE PROCEDURE. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: HIP PROCEDURE - ANTERIOR HIP ARTHROPLASTY. DETAILED DESCRIPTION OF EVENT: "WOULD LIKE TO NOTIFY YOU THAT AN ALEXIS WOUND RETRACTOR CAT# C8204 LOT#: 1365929 EXPIRATION: 08/18/2022 TORE DURING A PROCEDURE." THE ACCOUNT MANAGER SPOKE WITH AND RECEIVED AN EMAIL FROM THE CUSTOMER ON 22NOV2019. THE CUSTOMER REPORTED THAT NO PATIENT INJURY OCCURRED. THE DATE OF THE EVENT WAS 21NOV2019. LIMITED INFORMATION WAS AVAILABLE AT THE TIME OF REPORTING. IT WAS UNKNOWN WHAT INSTRUMENTS WERE IN USE AT THE TIME OF THE EVENT. IT WAS UNKNOWN WHAT TYPE OF PROCEDURE WAS BEING PERFORMED. THE DEVICE IS AVAILABLE FOR RETURN. THE ACCOUNT MANAGER FORWARDED THE EMAIL TO APPLIED MEDICAL AT THE SAME TIME AS HE CALLED IN THE COMPLAINT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 26DEC2019 FROM [NAME] ACCOUNT MGR: "CUSTOMER STATED THAT SURGEON WAS USING ALEXIS-O DURING A HIP PROCEDURE. SHARP INSTRUMENTS AND/OR RETRACTORS CAUSED THE ALEXIS-O TO TEAR DURING THE PROCEDURE. FACILITY WILL START CARRYING ALEXIS ORTHO TO ENSURE PATIENT SAFETY." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 30DEC2019 FROM [NAME] ACCOUNT MGR: "CASE WAS AN ANTERIOR HIP ARTHROPLASTY. 'HIT WITH AN INSTRUMENT THAT CAUSED A SLIGHT TEAR IN THE OPAQUE MATERIAL.' ITEM WAS NOT DEFECTIVE. THE ALEXIS WAS DEPLOYED WHEN THE TEAR OCCURRED. THE SURGEON USING THE PRODUCT WAS [NAME]. ORIGINALLY THEY MENTIONED THAT THE PRODUCT WAS RETAINED. NOW THEY ARE SAYING THAT THEY DON¿T HAVE IT. I HAVEN'T BEEN ABLE TO ASCERTAIN WHETHER THE DEVICE WAS EVER SAVED IN THE FIRST PLACE. IF I HEAR ANYTHING FURTHER ON THIS MATTER I WILL PASS IT ALONG IMMEDIATELY." PATIENT STATUS: NO PATIENT INJURY OCCURRED AS A RESULT OF THE COMPLAINT EVENT. TYPE OF INTERVENTION: NI.

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    NAME OF PROCEDURE BEING PERFORMED: ANP. DETAILED DESCRIPTION OF EVENT: "WOULD LIKE TO NOTIFY YOU THAT AN ALEXIS WOUND RETRACTOR CAT# C8204. LOT#: 1365929 EXPIRATION: 08/18/2022 TORE DURING A PROCEDURE." THE ACCOUNT MANAGER SPOKE WITH AND RECEIVED AN EMAIL FROM THE CUSTOMER ON 22NOV2019. THE CUSTOMER REPORTED THAT NO PATIENT INJURY OCCURRED. THE DATE OF THE EVENT WAS (B)(6) 2019. LIMITED INFORMATION WAS AVAILABLE AT THE TIME OF REPORTING. IT WAS UNKNOWN WHAT INSTRUMENTS WERE IN USE AT THE TIME OF THE EVENT. IT WAS UNKNOWN WHAT TYPE OF PROCEDURE WAS BEING PERFORMED. THE DEVICE IS AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY OCCURRED AS A RESULT OF THE COMPLAINT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264213 C8402, M ALEXIS O WND PROT/RET 5/BX PROSTHESIS, FINGER, CONSTRAINED, METAL/POLYMER KWG APPLIED MEDICAL RESOURCES C8402 1365929 00607915117269

    Patients

    Seq Age Sex Outcome Treatment
    1