MAUDE Adverse Event Report: IN2BONES SAS; DRILL DIAM 3.0 - AO - LG110MM NON STERILE CANULATED 1.6MM

Catalog Number	G01 00091
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Common Device Name: DRILL DIAM 3.0 - AO - LG110MM NON STERILE CANULATED 1.6MM
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; FR 69130
• Manufacturer (Section G): IN2BONES SAS; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; FR 69130
• Manufacturer Contact: martin geertsema ; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; FR 69130
• MDR Report Key: 23093999
• Report Number: 3010470577-2021-03171
• Device Sequence Number: 18448017
• Product Code: HTW
• UDI-Device Identifier: 03760225713105
• UDI-Public: 3760225713105
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: G01 00091
• Device Lot Number: 1805032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 78 KG