MAUDE Adverse Event Report: INION OY INION COMPRESSON¿ INSTRUMENT; BONE TAP, REUSABLE

Model Number	1
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); Insufficient Information (4580)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After investigation, it is concluded that the ø 0.8 mm k-wire (non-inion device) has not been able to hold its alignment during drilling and has got stuck in the bone channel in an oblique position.While drilling the inion drill tap over the k-wire, the part of the k-wire inside the drill tap cannula has started to revolve with the drill tap instrument whilst the bent tip of the k-wire has stayed stationary and has been twisted and snapped broken.At the same time, the cutting edges of the tip of the drill tap have grinded against the bent k-wire and partially broken off.Based on design engineer evaluation, the drill tap broke due to k-wires being positioned obliquely within the bone canals, which eventually caused the drill tap tip breakage.
Event or Problem Description
During a knee ocd fixation, after the insertion of the first k-wire, inion drill tap broke at its tip.This was noticed after the insertion of the second k-wire, when the drill tap became more tightly stuck.Upon taking the drill tap out, it was discovered that the k-wire had broken inside the bone.At this point the first k-wire was also checked (screw was already inserted) and it was discovered that the first k-wire had also been broken inside the bone.The broken k-wire pieces were removed from posterior (popliteal) side, which added 60 minutes to the operation time.A small piece of the drill tap tip (approximately 1mm) was left inside the first screw tunnel.Based on surgeon's evaluation, the only harm to patient caused by the incident was an additional surgical scar to popliteal side.This event is being reported as it caused approximately a 60-minute delay to operation time and the removal of the broken k-wire pieces from the popliteal side caused a change in the original operation plan and resulted in an additional surgical scar to popliteal area.Also the inion drill tap broke during operation and a small piece from the drill tap tip was left inside the screw tunnel.Note: the k-wire used with the drill tap was not manufactured by inion.According to inion's instructions for use only inion k-wires should be used.

• Brand Name: INION COMPRESSON¿ INSTRUMENT
• Common Device Name: BONE TAP, 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: 23552040
• Report Number: 3003407235-2025-00016
• Device Sequence Number: 9457905
• Product Code: HWX
• UDI-Device Identifier: 06438408008061
• UDI-Public: 06438408008061
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K203105
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2025

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-2708
• Device Lot Number: 231017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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: K-WIRES (NOT MANUFACTURED BY INION).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown