MAUDE Adverse Event Report: IN2BONES SAS NEOSYS SINGLE USE SET COMPLETE; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Model Number	G02 10191
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Based on the information provided by the user, the tip of the single [?] use screwdriver fractured during screw insertion.The fragments fell into the surgical site and were retrieved, and no patient harm has been reported.The device involved will not be returned to the manufacturer, preventing a physical examination of the product.As part of the manufacturer's investigation, the batch documentation will be reviewed to identify any potential anomalies.Based on the information currently available, the root cause cannot be determined at this stage and the assessment remains ongoing.

• Brand Name: NEOSYS SINGLE USE SET COMPLETE
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): IN2BONES SAS; 97 allée alexandre borodine; immeuble sequoia 3; 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 ; 97 allée alexandre borodine; immeuble sequoia 3; saint-priest, 69800 ; FR 69800
• MDR Report Key: 24207183
• Report Number: 3010470577-2026-01131
• Device Sequence Number: 9809994
• Product Code: KDD
• UDI-Device Identifier: 03701337606275
• UDI-Public: 03701337606275
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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 10191
• Device Catalogue Number: G02 10191
• Device Lot Number: 2404374
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/21/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown