MAUDE Adverse Event Report: IN2BONES SAS NEOFUSE; SCREWDRIVER T8 TORX NON CANNULATED

Model Number	G01 01571
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a case, the driver tip became damaged while attempting to implant the screws (while putting the caps on).
Additional Manufacturer Narrative
Based on the investigation and the condition of the returned instruments, the event is most consistent with use-related damage.The twisted driver tips indicate the application of excessive torque or misalignment during screw implantation while seating the caps.No manufacturing defect or material anomaly was identified.The batch record 1902432 was compliant, and no systemic issue was detected.The event is therefore attributed to procedural handling during surgery, not to a device non conformity.
Event or Problem Description
It was reported during a case, the driver tip became damaged while attempting to implant the screws (while putting the caps on).

• Brand Name: NEOFUSE
• Common Device Name: SCREWDRIVER T8 TORX NON CANNULATED
• 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: 24687646
• Report Number: 3010470577-2020-02341
• Device Sequence Number: 18636164
• Product Code: HXX
• UDI-Device Identifier: 03760225717141
• UDI-Public: 03760225717141
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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 01571
• Device Catalogue Number: G01 01571
• Device Lot Number: 1902432
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Male