BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAFIX INSTRUMENTATION

    MDR report key: 21784861 · Received April 7, 2025

    Report

    Report Number
    3004549189-2025-00004
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    January 30, 2025
    Report Date
    March 13, 2025
    Manufacturer
    S.B.M. SAS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MARCH 13, 2025. ANALYSIS OF THE COMPLAINT / ADDITIONAL INFORMATION REQUESTED TO UNDERSTAND THE CIRCUMSTANCES OF THE INCIDENT: USE OF AN EYE BROACH AND A Ø4.5MM CANNULATED DRILL BIT: INSTRUMENT BATCHES NOT COMMUNICATED. NOT ENOUGH ELEMENTS IN OUR POSSESSION TO CONTINUE OUR INVESTIGATIONS INTERNALLY. NO PHOTOS. QUESTIONS TO THE INITIAL CORRESPONDENT: WHAT IS THE PATIENT'S CURRENT CONDITION? HAS AN INFECTION OCCURRED? IS THE PATIENT UNDER SPECIAL CARE? WHAT IS THE BATCH NUMBER OF THE EYE PIN USED? WHAT IS THE NUMBER OF THE CANNULATED DRILL USED? DESCRIPTION OF THE DEPOSIT OBSERVED: WHEN WAS IT OBSERVED? WAS IT VISIBLE TO THE NAKED EYE? DO YOU HAVE A PHOTO OF THE IMPURITY? HAVE YOU CARRIED OUT AN ANALYSIS OF THIS DEPOSIT? IF SO, WHAT WAS THE RESULT? DID THESE INSTRUMENTS FOLLOW THE USUAL STERILIZATION PROTOCOL? HAVE YOU REPORTED THIS INCIDENT TO THE ANSM? IF SO, CAN YOU SEND ME THE DECLARATION FORM AND, IF AVAILABLE, THE ANSM FILE NUMBER? ARE THESE INSTRUMENTS AVAILABLE? RESULT OF INVESTIGATION: THE BATCH NUMBER OF THE INSTRUMENTS USED WAS NOT COMMUNICATED: NO HISTORICAL VERIFICATION POSSIBLE. AFTER INVESTIGATION BY THE HOSPITAL CENTER, THE DEPOSIT APPEARED TO BE DRIED BLOOD. ACCORDING TO THEIR INTERNAL SURVEY BETWEEN THE REPORTING DEPARTMENT AND THE STERILIZATION DEPARTMENT, THE UNDESIRABLE PRESENCE OF THIS DEPOSIT, OBSERVED DURING THE SURGERY, IS NOT DIRECTLY LINKED TO THE ANCILLARIES DELIVERED, BUT STEMS FROM A MALFUNCTION IN THE PROCESSING AND STERILIZATION OF REUSABLE INSTRUMENTS WITHIN THE HEALTH ESTABLISHMENT. THEY ARE WORKING INTERNALLY ON THIS MALFUNCTION AND ON THE VIGILANCE REQUIRED FOR REUSABLE DM TO BE STERILIZED. NO CORRECTIVE ACTION IMPLEMENTED BY SBM. INCIDENT VERY ISOLATED. THE HOSPITAL CENTER IS WORKING ON THE MALFUNCTION. THE FILE IS CLOSED. ____________________________________________________

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN FRANCE. EVENT DESCRIPTION COMMUNICATED. "DURING A KNEE LIGAMENTOPLASTY, A DEPOSIT APPEARED ON THE EYE PIN AFTER CANNULATED WICKING. WE ARE NOT SURE OF THE ORIGIN OF THIS DEPOSIT, BUT IT'S PROBABLY DIRT THAT WAS INSIDE THE DRILL BIT. POTENTIAL RISKS: INFECTION". IMMEDIATE MEASURES: ANTIBIOTIC PROPHYLAXIS AT THE START OF THE PROCEDURE AND ABUNDANT SALINE LAVAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655288 LIGAFIX INSTRUMENTATION EYELET PIN Ø 2.5 MM - L 400 MM X10 LXH S.B.M. SAS NOT COMMUNICATED

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Other EYELET PIN USED WITH A CANNULATED WICKING/LOT UNCK.