MAUDE Adverse Event Report: IN2BONES SAS IBS¿; DRILL DIAM 3.0 MM AO ATTACHMENT CANNULATED NS LG110 MM

Model Number	G01 00091
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The k wire came out of the drill bit cannula and became stuck in the cannula window.The surgeon stopped the motor rotation before any further damage occurred.According to the operator, the additional bars added to the drill bit cannulas are considered unsafe.
Additional Manufacturer Narrative
N/a.
Additional Manufacturer Narrative
No product was returned for evaluation, preventing confirmation of the reported event.Similar incidents involving kirschner (k-wires) coming out of reusable drills have been observed in the field and have been examined as part of post-market surveillance activities.The design of the reusable drills, including their windows, has been previously validated and complies with manufacturing and reprocessing requirements.Based on the available information, the event appears to be related to the conditions of use rather than a confirmed product defect.No specific root cause can be determined without the device.
Event or Problem Description
The k wire came out of the drill bit cannula and became stuck in the cannula window.The surgeon stopped the motor rotation before any further damage occurred.According to the operator, the additional bars added to the drill bit cannulas are considered unsafe.

• Brand Name: IBS¿
• Common Device Name: DRILL DIAM 3.0 MM AO ATTACHMENT CANNULATED NS LG110 MM
• Manufacturer (Section D): IN2BONES SAS; immeuble sequoia 3; 97 allée alexandre borodine; saint-priest, 69800 ; FR 69800
• Manufacturer (Section G): IN2BONES SAS; immeuble sequoia 3; 97 allée alexandre borodine; saint-priest, 69800 ; FR 69800
• Manufacturer Contact: benjamin krempel ; immeuble sequoia 3; 97 allée alexandre borodine; saint-priest, 69800 ; FR 69800
• MDR Report Key: 24725527
• Report Number: 3010470577-2020-10051
• Device Sequence Number: 10248369
• Product Code: GFG
• UDI-Device Identifier: 03760225713105
• UDI-Public: 03760225713105
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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 Model Number: G01 00091
• Device Catalogue Number: G01 00091
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown