BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS BURRS

    MDR report key: 14460390 · Received May 20, 2022

    Report

    Report Number
    3010470577-2022-04222
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 21, 2022
    Report Date
    July 22, 2022
    Manufacturer
    IN2BONES SAS
    Product Code
    GFF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PERCUTANEOUS BURRS ARE INDICATED FOR FOREFOOT MINI-INVASIVE AND PERCUTANEOUS SURGERY. SHANNON BURRS ARE SPECIFICALLY INTENDED TO BE USED FOR: - OSTEOTOMY OF M1 AND/OR OF P1 - ALL SURGICAL BONE PROCEDURES OF THE LESSER TOES - CONTOURING OF METATARSAL HEADS THE PERCUTANEOUS BURRS ARE SUPPLIED STERILE, FOR SINGLE-USE ONLY. THEY ARE INTENDED TO BE USED IN A HOSPITAL, BY AN ORTHOPAEDIC SURGEON, ON A SKELETALLY MATURE POPULATION OF PATIENTS. TWO SHANNON BURRS DIAM2 LG20 BROKE DURING A DISTAL METATARSAL MINI-INVASIVE OSTEOTOMY PROCEDURE IN THE FOOT. A SIGNIFICANT DELAY IN SURGERY DURATION WAS REPORTED, AS THE SURGEON HAD TO REMOVE THE BROKEN PIECES. THE SURGERY WAS COMPLETED THANKS TO THE OTHER BURRS OF THE PACK OF 5. NO OTHER CLINICAL CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    PERCUTANEOUS BURRS ARE INDICATED FOR FOREFOOT MINI-INVASIVE AND PERCUTANEOUS SURGERY. SHANNON BURRS ARE SPECIFICALLY INTENDED TO BE USED FOR: OSTEOTOMY OF M1 AND/OR OF P1, ALL SURGICAL BONE PROCEDURES OF THE LESSER TOES, CONTOURING OF METATARSAL HEADS. THE PERCUTANEOUS BURRS ARE SUPPLIED STERILE, FOR SINGLE-USE ONLY. THEY ARE INTENDED TO BE USED IN A HOSPITAL, BY AN ORTHOPAEDIC SURGEON, ON A SKELETALLY MATURE POPULATION OF PATIENTS. TWO SHANNON BURRS DIAM2 LG20 BROKE DURING A DISTAL METATARSAL MINI-INVASIVE OSTEOTOMY PROCEDURE IN THE FOOT. A SIGNIFICANT DELAY IN SURGERY DURATION WAS REPORTED, AS THE SURGEON HAD TO REMOVE THE BROKEN PIECES. THE SURGERY WAS COMPLETED THANKS TO THE OTHER BURRS OF THE PACK OF 5. NO OTHER CLINICAL CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200110 PERCUTANEOUS BURRS PERCUTANEOUS BURRS GFF IN2BONES SAS G01 01512 2110004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other