BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23093999 · Received September 19, 2025

    Report

    Report Number
    3010470577-2021-03171
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    February 21, 2021
    Report Date
    September 19, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HTW
    UDI-DI
    03760225713105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REGARDING THE DRILL : BATCH RECORD 1805032 IS FOUND TO BE COMPLIANT: (B)(4) DRILLS WERE RELEASED ON 29/OCT/2015. THE PRODUCTS WERE MANUFACTURED AS PER DRAWING IN FORCE AT THAT TIME (G01 009 REV04), AS PER OF-18020061-F2. NCF-1809-03 IS NOT RELATED TO THE EVENT REPORTED IN THE COMPLAINT SINCE IT IS RELATED TO THE LOSS OF A DRILL AT PHEN'X DURING MANUFACTURING OF THE BATCH. REGARDING THE K-WIRE : NO REFERENCE NOR BATCH NUMBER AVAILABLE FOR THIS K-WIRE INVOLVED IN THIS COMPLAINT. NO INFORMATION AVAILABLE ON THIS DEVICE: IT IS POSSIBLE THAT THIS SINGLE USE DEVICE WAS REUSED. THE INSTRUMENTS WERE MANUFACTURED ACCORDING TO DRAWING IN FORCE AT TIME (G01 009 REV 04). A THE DATE OF THE EVENT, THIS DRAWING IS AT ITS VERSION 05: THE CHANGE IMPLEMENTED BEING RELATED ONLY TO MARKING SPECIFICATIONS, IT COULD NOT HAVE PREVENTED THE EVENT REPORTED IN THIS COMPLAINT. MOREOVER, THE DESIGN (FUNCTIONALITIES AND PERFORMANCES) OF IN2BONES REUSABLE DRILLS AND SINGLE USE K-WIRES ARE NOT QUESTIONED, SINCE NO NEGATIVE FEEDBACKS WERE TO BE REPORTED ON THOSE INSTRUMENTS (REFER TO IBS PMS MEETING REPORT V03 AND K-WIRES PMS MEETING PERFORMED ON 17/DEC/2019). ROOT CAUSE HYPOTHESIS : INCORRECT USE OF THE DRILL (APPLICATION OF AN EXCESSIVE LOAD) AND / OR REUSE OF THE SINGLE USE K-WIRE.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: PATIENT INITIALS CHA, MALE, AGED 61 YEARS, WEIGHT 78 KG. DURING THE USE (FOR A RIGHT SUBTALAR ARTHRODESIS), THE CANNULATED DRILL BROKE. IT WAS REMOVED FROM THE PATIENT, WITH THE K-WIRE STUCK INSIDE. NO CLINICAL CONSEQUENCES. THIS REPORTABLE EVENT IS PART OF A REMEDITION RESULTING FROM A 483 LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983263 DRILL DIAM 3.0 - AO - LG110MM NON STERILE CANULATED 1.6MM HTW IN2BONES SAS 1805032 03760225713105

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male