MAUDE Adverse Event Report: IN2BONES SAS NEOSYS; NEOSYS SET SINGLE USE INSTRUMENTS

Model Number	G02 10001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
N/a.
Event or Problem Description
During a mini-open chevron osteotomy for hallux valgus, two sterile, single-use torx 8 screwdriver blades (i2b ibs sterile instruments - g0210001, 3.0/3.5) fractured at the head during the insertion of ibs screws (s35st120 and s35st122).All fragments were removed, and no metal debris remained in the patient's body.According to the information provided, the chamfering drill was not used during screw insertion, which may have contributed to the shaft fractures.
Event or Problem Description
During a mini-open chevron osteotomy for hallux valgus, two sterile, single-use torx 8 screwdriver blades (i2b ibs sterile instruments - g0210001, 3.0/3.5) fractured at the head during the insertion of ibs screws (s35st120 and s35st122).All fragments were removed, and no metal debris remained in the patient's body.According to the information provided, the chamfering drill was not used during screw insertion, which may have contributed to the shaft fractures.
Additional Manufacturer Narrative
Based on the information provided by the complaint initiator and the photographic documentation, the event is confirmed as a use related malfunction.Both sterile single use drivers broke at the head during screw insertion.The screws were inserted without prior countersinking, which, although optional, is recommended in cases of dense bone to reduce insertion torque.The absence of countersinking likely increased the mechanical stress on the driver shafts and contributed to their failure.All fragments were retrieved, and the procedure was completed without injury or clinical consequence.

• Brand Name: NEOSYS
• Common Device Name: NEOSYS SET SINGLE USE INSTRUMENTS
• 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
• MDR Report Key: 24696766
• Report Number: 3010470577-2020-06021
• Device Sequence Number: 13378870
• Product Code: KDD
• UDI-Device Identifier: 03760225712191
• UDI-Public: 03760225712191
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: G02 10001
• Device Catalogue Number: G02 10001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown