BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS BURR

    MDR report key: 12008079 · Received June 16, 2021

    Report

    Report Number
    3010470577-2021-05151
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 11, 2021
    Report Date
    August 5, 2021
    Manufacturer
    IN2BONES SAS
    Product Code
    GFF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 0

    DURING AN OSTEOTOMY OF THE FOOT 1ST METATARSAL, 2 PERCUTANEOUS BURRS USED TO WORK ON THE BONE BROKE. A SIGNIFICANT DELAY IN SURGERY DURATION WAS REPORTED, NO OTHER CLINICAL CONSEQUENCES ARE KNOWN TO DATE. PRELIMINARY INVESTIGATION SHOWED THAT THE BATCH RECORD WAS COMPLIANT. OCCURRENCE OF THE EVENT WHEN THE FIRST REPORT WAS WRITTEN WAS OF 0,98% ; THE WORST-CASE CONSEQUENCE FOR THE PATIENT IS A SIGNIFICANT DELAY IN SURGERY DURATION. THE TWO DEVICES WERE RETURNED TO IN2BONES THE 25/MAY/2021 AND SENT TO THE MANUFACTURING SUBCONTRACTOR FOR ANALYSIS ; AFTER DESTRUCTIVE TESTING PERFORMED THE 26/MAY/2021, THE 2 BURRS WERE FOUND TO BE COMPLIANT TO SPECIFICATIONS. TO DATE (AUGUST 2021), NO NEW OCCURRENCE OF BREAKAGE WAS RECORDED SINCE THIS EVENT WAS REPORTED. OCCURRENCE OF THE EVENT IS NOW OF 0,83%. THIS BURR REFERENCE WAS SUBJECT TO A CHANGE CONTROL (DM2102-04), TO ADJUST THE DRAWINGS MANUFACTURING TOLERANCE TO PREVENT BREAKAGES FROM OCCURING AGAIN. OCCURRENCE OF THE EVENT ON BURRS BATCHES SOLD AFTER THE CHANGE CONTROL ONLY IS OF 0,55%. THE CURRENT RISK MANAGEMENT FILE IS ALIGNED WITH THIS ASSESSMENT. THIS IS THE FIRST AND ONLY REPORTING OF BREAKAGES SINCE THE CHANGE CONTROL WAS FINALIZED THE 19TH OF APRIL 2021. GIVEN THAT DESTRUCTIVE TESTING PERFORMED CONCLUDED THAT THE DEVICES WERE COMPLIANT TO SPECIFICATIONS, AND THAT THE OCCURENCE IS RARE (<1%), THE MOST PROBABLE ROOT CAUSE IS UNINTENDED USE ERROR WITH EXCESSIVE FORCE APPLIED ON THE BURR. IN2BONES WILL CONTINUE TO CLOSELY MONITOR THIS TYPE OF EVENTS.

    Description of Event or Problem · 1

    DURING AN OSTEOTOMY OF THE FOOT 1ST METATARSAL, 2 PERCUTANEOUS BURRS USED TO WORK ON THE BONE BROKE. A SIGNIFICANT DELAY IN SURGERY DURATION WAS REPORTED, NO OTHER CLINICAL CONSEQUENCES ARE KNOWN TO DATE. PRELIMINARY INVESTIGATION SHOWED THAT THE BATCH RECORD WAS COMPLIANT. OCCURRENCE OF THE EVENT IS OF 0,98% ; THE WORST-CASE CONSEQUENCE FOR THE PATIENT IS A SIGNIFICANT DELAY IN SURGERY DURATION. THE TWO DEVICES WERE RETURNED TO IN2BONES THE (B)(6) 2021 AND SENT TO THE MANUFACTURING SUBCONTRACTOR FOR ANALYSIS ; AFTER DESTRUCTIVE TESTING PERFORMED THE (B)(6) 2021, THE 2 BURRS WERE FOUND TO BE COMPLIANT TO SPECIFICATIONS. INVESTIGATION AND ROOT CAUSE DETERMINATION ARE STILL IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910111 PERCUTANEOUS BURR PERCUTANEOUS BURR, GFF IN2BONES SAS G01 01512 2104006

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other