MAUDE Adverse Event Report: IN2BONES SAS IBS¿; CANNULATED POWER TIP TORX7 FOR 0.8 MM K-WIRE

Model Number	G01 00201
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Surgical bunion correction with osteotomies.Bone had been cut and was being fixed with surgical compression screws.As screw was inserted, screw driver tip sheared off inside head of the screw.The screw was in position and stable, the tip of the screwdriver was recovered and no harm was caused.

• Brand Name: IBS¿
• Common Device Name: CANNULATED POWER TIP TORX7 FOR 0.8 MM K-WIRE
• Manufacturer (Section D): IN2BONES SAS; 97, allée alexandre borodine; immeuble sequoia 3; st-priest, 69800 ; FR 69800
• Manufacturer (Section G): IN2BONES SAS; 97 allée alexandre borodine; immeuble sequoia 3; saint-priest, 69800 ; FR 69800
• Manufacturer Contact: benjamin krempel ; 97, allée alexandre borodine; immeuble sequoia 3; st-priest, 69800 ; FR 69800
• MDR Report Key: 25453422
• Report Number: 3010470577-2026-06031
• Device Sequence Number: 10450206
• Product Code: HXX
• UDI-Device Identifier: 03760225712139
• UDI-Public: 03760225712139
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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 00201
• Device Catalogue Number: G01 00201
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 06/30/2026
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female