MAUDE Adverse Event Report: IN2BONES SAS KIRSCHNER WIRE; K-WIRE NO STERILE DIAM 0.8 MM LENGTH 70 MM 1 SHARP TIP

Model Number	K10 NS070
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the guide pin bent and fractured when removal was attempted.A second fragment remained in the patient's foot.No complications were reported by the facility.
Additional Manufacturer Narrative
The device was not returned; therefore, no evaluation could be conducted.Batch record review showed no nonconformities.The device met all specifications.Based on the event description, the most probable root cause is device use, specifically potential reuse or excessive mechanical load on a single-use k-wire.No manufacturing or design defect identified.No remedial action required, and the risk remains within the acceptable range.
Event or Problem Description
During the procedure, the guide pin bent and fractured when removal was attempted.A second fragment remained in the patient's foot.No complications were reported by the facility.

• Brand Name: KIRSCHNER WIRE
• Common Device Name: K-WIRE NO STERILE DIAM 0.8 MM LENGTH 70 MM 1 SHARP TIP
• 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: 24686329
• Report Number: 3010470577-2020-02261
• Device Sequence Number: 18568401
• Product Code: HTY
• UDI-Device Identifier: 03760225711569
• UDI-Public: 03760225711569
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: K10 NS070
• Device Catalogue Number: K10 NS070
• Device Lot Number: 1902240
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 03/25/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown