MAUDE Adverse Event Report: INION OY INION COMPRESSON¿ INSTRUMENT; ORTHOPAEDIC GUIDEWIRE, REUSABLE

Model Number	1
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An osteochondral talus fracture was fixed with 2.7 mm inion compression screws.After successful fixation of the fracture fragment, a fluoroscopy was taken prior to wound closure.The picture revealed that the 0.8 mm inion k-wire used had broken during the operation and an approximately 26 mm k-wire fragment remained inside the talus bone.The surgeons decided to close the surgical wound and take a ct the following day to evaluate if reoperation is needed to remove the k-wire fragment.No immediate harm or clinical deterioration was observed.The patient underwent the ct scan the following day where it was evaluated that the k-wire passes through the bone, but does not enter to the subtalar joint, so no intervention were required.Currently the fragment does not cause clinical symptoms to the patient.This incident is considered a malfunction as the k-wire broke unexpectedly during operation and a fragment of the k-wire was left inside the patient.Currently this incident does not cause clinical symptoms to the patient, no change in the surgical plan was implemented, there was no delay in operation and no reoperation was deemed necessary at this point.The fixation of the actual osteochondral fracture fragment was successful with the inion compression screw.However, a foreign body was left in the patient which could potentially cause harm in the future if it e.G.Were to migrate and would require removal.Also, if a similar malfunction would repeat, the k-wire could reach the subtalar joint which would require reoperation.
Additional Manufacturer Narrative
The operation was successful, but a thin inion compression¿ k-wire broke during the procedure, likely due to the hardness of the bone and the young age of the patient.The breakage occurred while tapping the bone channel, and the k-wire was inserted without a drill sleeve, which increased the risk of breakage.The issue was only noticed before wound closure, and a fragment of the broken k-wire was left in the talar bone.Although the fragment does not currently cause symptoms, it could pose risks in the future if it migrates and requires removal.The device was found to be within specifications, and no other complaints were reported for this batch.The event was classified as a malfunction, and no product recall or corrective actions are needed, as instrument breakage is a known risk for thin devices.The instructions for use (ifu) for the inion compression¿ screw highlight the importance of proper use and regular inspection of surgical instruments to prevent wear and damage.

• Brand Name: INION COMPRESSON¿ INSTRUMENT
• Common Device Name: ORTHOPAEDIC GUIDEWIRE, REUSABLE
• Manufacturer (Section D): INION OY; lääkärinkatu 2; tampere, 33520 ; FI 33520
• Manufacturer (Section G): INION OY; lääkärinkatu 2; tampere, 33520 ; FI 33520
• Manufacturer Contact: kati marttinen ; lääkärinkatu 2; tampere, 33520 ; FI 33520
• MDR Report Key: 24255865
• Report Number: 3003407235-2026-00004
• Device Sequence Number: 9658280
• Product Code: FZX
• UDI-Device Identifier: 06438408008917
• UDI-Public: 06438408008917
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1
• Device Catalogue Number: IFS-9063
• Device Lot Number: 923576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IFS-2708, DRILL TAP Ø2.7 MM, CANNULATED
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown