MAUDE Adverse Event Report: INION OY INION COMPRESSON¿ SCREW; BONE SCREW

Model Number	1
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Loss of fracture reduction (4901)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No other complaints have been received related to this product batch, and the batch records show that the product batch is in specification.It has been observed that there is a learning curve associated with the insertion of the inion compression screws due to the minimized amount of material.Overall, this was a challenging fracture and the bone quality in the diaphysis was extremely hard.
Event or Problem Description
Two inion compresson screws (2.7*12 mm) were used to fix metacarpal fractures in a 17-year-old patient.The fourth metacarpal bone had a fracture at the diaphysis, and it was difficult to align the ends of the bones.While threading the screw hole, a small piece of bone broke off.This did not impact the planned operation and after threading, the surgeon started inserting one inion compresson screw to the threaded screw hole.However, during insertion, the screw head broke when it hit the surface of the bone and the screw would no longer turn.The screw was left in place and its head was cut off with cutters.The fracture was finally repaired with cerclage metal wire and one transverse k-wire.The surgery took approximately 30 minutes longer, including the installation of the metal wire and k-wire.The fracture at the distal end of the third metacarpal (middle finger bone) was successfully fixed with the inion compresson screw.The surgeon was satisfied with the fixation.

• Brand Name: INION COMPRESSON¿ SCREW
• Common Device Name: BONE SCREW
• 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: 23288967
• Report Number: 3003407235-2025-00012
• Device Sequence Number: 5469956
• Product Code: HWC
• UDI-Device Identifier: 06438408008122
• UDI-Public: 06438408008122
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K203105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2026
• Device Model Number: 1
• Device Catalogue Number: OSH-2712
• Device Lot Number: 2301013
• 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: 09/23/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CERCLAGE METAL WIRE (UNKNWON MANUFACTURER); K-WIRE (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Unknown