BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE SOFT TISSUE ANCHOR

    MDR report key: 14597001 · Received June 3, 2022

    Report

    Report Number
    3007593722-2022-00001
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    May 12, 2022
    Report Date
    July 8, 2022
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    MBI
    PMA / PMN Number
    K123350
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMOVAL IS SET TO OCCUR AT THE END OF (B)(6) 2022 AND FURTHER DETAILS WILL BE OBTAINED. THE PATIENT INFORMATION, ORIGINAL IMPLANT DATE AND LOT INFORMATION ARE UNKNOWN AT THIS TIME. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4) INVESTIGATION WAS COMPLETED ON 01JUL2022. IN CONCLUSION, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT HAS BEEN DETERMINED TO BE AN ERROR MADE BY THE SURGEON DURING THE ORIGINAL IMPLANTATION CASE IN (B)(6) 2021 RESULTING IN A BREAKAGE OF THE ECLIPSE METAL END OF THE CANNULA. ADDITIONALLY, THERE WAS A FAILURE TO DETECT THAT PART OF THE METAL RETENTION ROD REMAINED WITH THE ECLIPSE IMPLANT AT THE SURGICAL SITE, AS IS SPECIFIED IN MK-10091 ECLIPSE IFU STEP 11. REVIEW OF COMPLAINT HISTORY SHOWS THAT FOR (B)(4). THUS, DUE TO THE OVERALL LOW COMPLAINT / SALES RATE FOR THIS FAILURE MODE, NO CORRECTIVE ACTION IS NECESSARY TO ADDRESS THIS ISSUE OR THE FACT THAT THERE WAS A LACK OF OBSERVATION OF THIS ISSUE DURING THE INITIAL SURGERY. HOWEVER, DURING THIS INVESTIGATION IT WAS OBSERVED THAT THIS FAILURE MODE OF "METAL COMPONENT OF ECLIPSE DELIVERY ROD BREAKS AND REMAINING IN PATIENT POST-OPERATIVELY" IS NOT CAPTURED IN ED-50142 ECLIPSE RISK MANAGEMENT DOCUMENT. THUS, DESPITE A LOW COMPLAINT RATE, AN ANALYSIS IS NEEDED INTO THE FULL RISK TO THE PATIENT OF ANY OF THE METAL COMPONENTS OF THE DELIVERY ROD REMAINING IN THE PATIENT POST-OPERATIVELY. CAPA 2022-07-001 HAS BEEN INITIATED TO EVALUATE THE ECLIPSE RISK ASSESSMENT DOCUMENTS AND DETERMINE IF AN UPDATE IS NEEDED TO ADDRESS THIS FAILURE MODE. THE RESULTS OF THIS ASSESSMENT WILL ALSO DETERMINE IF ADDITIONAL ACTIONS MAY BE NECESSARY FOR THE ECLIPSE DESIGN, MANUFACTURING PROCESS OR SURGICAL TECHNIQUE BASED ON THE RISK OF THIS METAL REMAINING IN THE PATIENT POST-OPERATIVELY. DESPITE THE OBSERVATION THAT THE RISK ASSESSMENT FOR ECLIPSE NEEDS A NEW EVALUATION FOR THIS FAILURE, THE INVESTIGATION DETERMINED THAT THE EXISTING MANUFACTURING PROCESS CONTROLS AND SURGICAL TECHNIQUE / IFU ARE ADEQUATE AND DO NOT NEED MODIFICATION AT THIS TIME.

    Description of Event or Problem · 0

    MEDSHAPE WAS NOTIFIED REGARDING A PATIENT WHO HAD PAIN AND SWELLING AT THE CALCANEUS AND CAME IN FOR REVIEW TO FIND OUT THAT A SMALL FRAGMENT OF THE IMPLANTED ECLIPSE DEVICE HAD REMAINED AT THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031560 ECLIPSE SOFT TISSUE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI MEDSHAPE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other