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	05/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During two separate surgical procedures, a kirschner wire (k-wire) broke inside the patient's toe during use.The broken wire was not retrieved or preserved.Lot number could not be confirmed and the product expiration date was unavailable.
Additional Manufacturer Narrative
N/a.
Additional Manufacturer Narrative
A guide pin fractured during an intraoperative procedure.According to the reporting healthcare facility, a small fragment remained inside the bone.The surgeon stated that the retained fragment did not impact the clinical outcome, and the procedure was completed as planned.The final implant was successfully placed without complication.The device involved in the event was not returned.As a result, no visual inspection, functional testing, could be performed.Based on the information provided, the cause of the fracture could not be determined.No patient harm was reported, and no further action was required.
Event or Problem Description
During two separate surgical procedures, a kirschner wire (k-wire) broke inside the patient's toe during use.The broken wire was not retrieved or preserved.Lot number could not be confirmed and the product expiration date was unavailable.

• 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, ; FR
• Manufacturer Contact: benjamin krempel ; immeuble sequoia 3; 97 allée alexandre borodine; saint-priest, 69800 ; FR 69800
• MDR Report Key: 24661005
• Report Number: 3010470577-2019-05201
• Device Sequence Number: 18441162
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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
• 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: 05/13/2019
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown