BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL DIAM 3.0 - AO - LG110MM NON STERILE CANULATED 1.6MM

    MDR report key: 23095811 · Received September 19, 2025

    Report

    Report Number
    3010470577-2021-11171
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    November 16, 2021
    Report Date
    September 19, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HTW
    UDI-DI
    03760225713105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORD 1809019 AND OF-18070274-F1 WERE REVIEWED AND FOUND TO BE COMPLIANT. 105 PRODUCTS WERE RELEASED ON FEBRUARY 21ST, 2019. THE DEVICES HAVE A LOW HRC BUT ITS VALUE IS WITHIN THE ACCEPTABLE RANGE. . BATCH RECORD 2101108 AND OF-21010075 WERE REVIEWED AND FOUND TO BE COMPLIANT. 56 PRODUCTS WERE RELEASED ON MARCH 17TH, 2021. THE DEVICES HAVE A LOW HRC BUT ITS VALUE IS WITHIN THE ACCEPTABLE RANGE. . BATCH RECORD 1706211 AND OF-17080153 WERE REVIEWED AND FOUND TO BE COMPLIANT. 125 PRODUCTS WERE RELEASED ON SEPTEMBER 29TH, 2017. PRODUCTS NOT RETURNED. THE DEFECT IS VISUALLY CONFIRMED THROUGH THE PICTURES PROVIDED BY THE COMPLAINT INITIATOR. FOR THE 4 INVOLVED INSTRUMENTS, THE BREAKAGE HAPPENED NEAR THE WINDOW OF THE INSTRUMENT. DRILL G01 00091 IS INTENDED TO BE USED FOR THE IMPLANTATION OF DIAMETER 4.5MM IBS C/N SCREWS. THE INSTRUMENTS WERE MANUFACTURED ACCORDING TO DRAWING IN FORCE AT TIME (G01 009 REV 04 AND 05). AT THE DATE OF THE EVENT, THIS DRAWING IS AT ITS REVISION 06. THE CHANGES IMPLEMENTED BETWEEN THOSE REVISIONS COULD NOT HAVE PREVENTED THE EVENT REPORTED IN THIS COMPLAINT: . UPDATE FROM REVISION 04 TO 05 IS RELATED TO THE MARKING OF THE AO PART. . UPDATE FROM REVISION 05 TO 06 IS RELATED TO THE ADDITION OF A RAW MATERIAL STANDARD REFERENCE KEEPING THE ASTM F899. IT IS TO BE NOTED THAT, AS DESCRIBED IN IBS CN PMS MEETING REPORTS REV 04 AND 05, SEVERAL COMPLAINTS HAVE BEEN REPORTED ON K-WIRES THAT SLID-OUT OF THE DRILL THROUGH THE WINDOW DURING SURGERY (CANNULATED DRILLS FOR MID HIND FOOT SURGERIES); LEADING TO THE OPENING OF A DESIGN CHANGE (DM2101-13). THE AIM OF THIS CHANGE IS TO ASSESS THE POSSIBILITY TO REMOVE THE WINDOW FORM THOSE DRILLS DESIGN (THE WINDOW EXISTS IN THE DRILLS' DESIGN FOR RAW MATERIAL SUPPLY REASONS AND FOR STEAM STERILIZATION). THE EVENT REPORTED IN THIS COMPLAINT SEEMS TO BE RELATED TO WEAR FROM USE AND IS NOT RELATED TO THE INSTRUMENT DESIGN. HOWEVER, THE REMOVAL OF THE WINDOW FROM THE INSTRUMENT, MANAGED AS PER DM2101-13, MIGHT PREVENT NEW OCCURRENCES OF THIS TYPE OF INCIDENT.

    Description of Event or Problem · 0

    REFER TO F. FOGAROTTO (FROM THE DISTRIBUTOR COMPANY IN ITALIA) EMAIL DATED ON (B)(6) 2021: « WE HAVE A PROBLEM WITH 1.6MM DRILL REF. (B)(4). IN THE LAST PERIOD THESE DRILLS BREAK AT EACH SURGERY. I THOUGH IT WAS THE SURGEON'S MISTAKE, BUT WHEN I TOLD THEM TO BE CAREFUL, TO FOLLOW THE SURGICAL TECHNIQUE AND POSSIBLY GIVE ME FEEDBACK, THE DRILL BROKE AGAIN. THE DRILLS BROKE IN THE OPENED PART. I DON'T KNOW IF THE PROBLEM LIES IN THE DESIGN BUT I THINK YOU SHOULD GO DEEPER IN THAT. » ADDITIONAL INFORMATION RECEIVED BY E-MAIL ON NOVEMBER 17TH, 2021: « - YES, THE SURGERIES WERE COMPLETED WITHOUT ANY PROBLEMS. - NO, THERE WERE NO PARTICULAR CONDITIONS. 2 DIFFERENT SURGEON, 4 DIFFERENT PATIENTS, DIFFERENT AGES, DIFFERENT INDICATIONS, DIFFERENT IMPLANT SITE. - WE GOT ANOTHER BROKEN DRILL JUST YESTERDAY. HERE THE BATCH NUMBERS: 1809019, 1706211 (X2), 2101108. » "THE BROKEN DRILLS ARE NEW, NO SIGNS OF WEAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398832 DRILL DIAM 3.0 - AO - LG110MM NON STERILE CANULATED 1.6MM DRILL HTW IN2BONES SAS 1809019; 1706211 ; 2101108 03760225713105

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown