MAUDE Adverse Event Report: INION OY INION FREEDOMSCREW; FIXATION SCREW

Model Number	OSA-2740
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information was requested related to how the fracture had ossified, whether the fracture line/bones had remained in place, how the screws were positioned, and was there any x-rays available of the case.No further information was received, and therefore there is not enough information for concluding that the adverse event would have been caused or contributed by the inion device or by the operation technique.Final release documentation of the respective batch was reviewed and the material, dimensional, and mechanical properties of the batch were within the specification.Additionally, inion has not received other complaints related to this batch, or similar complaints for the inion freedomscrew device.
Event or Problem Description
The patient had a fracture of the right radial head and underwent internal fixation with fracture osteotomy and reduction.In the surgery two inion 2.7 x 40 mm freedomscrews were used to fix the bone block.The patient was rechecked 3 months after the operation for limitation of flexion and extension of the right finger and right elbow joint, which was suspected to be caused by the use of absorbable screws during the operation.Initial treatment for the patient´s limited mobility was active rehabilitation and functional exercise.

• Brand Name: INION FREEDOMSCREW
• Common Device Name: FIXATION 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: 18308497
• Report Number: 3003407235-2023-00010
• Device Sequence Number: 6152333
• Product Code: HWC
• UDI-Device Identifier: 06438408003240
• UDI-Public: 06438408003240
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2023

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: 05/01/2026
• Device Model Number: OSA-2740
• Device Catalogue Number: OSA-2740
• Device Lot Number: 2305001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female