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

Model Number	OSC-4555
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was verified that there are no other complaints or nonconformities related to the lot 2307022.Final release documentation of osc-4555, lot 2307022 was reviewed.Sterilization dose and dimensional and mechanical properties of the lot were within the specification.Tyvek- and aluminum seals of inspected pouches passed for the visual inspection.There are no customer complaints or nonconformities concerning sterility related to this sterilization lot.Based on the information inion has received, the patient's blood sugar control was poor, which was evaluated by the surgeon to be the cause of wound healing problems.The patient also suffered from hypertension grade 3, which may also cause wound healing problems.After debridement and antibiotic treatment, the local infection type symptoms disappeared and the wound healed.Bacterial infection is a surgery-related risk, and this risk always exists when surgery is being performed, regardless which type of fixation implants are used.This risk is increased if the patient suffers from diabetes-related poor glycemic control.The implantation site may be exposed to microbes both intraoperatively or postoperatively during wound healing period, which is often prolonged in cases of diabetic poor blood sugar control.In case of infection, biofilm can form on both metallic and biodegradable implants.Scientific publications have shown that the risk of bacterial infection is equal regardless of which type of implants are used (metal vs.Biodegradable).The implant material degradation related inflammatory tissue reactions can sometimes occur after using biodegradable implants but are usually seen much later when the biodegradable implants start to degrade, approximately 1-2 years after operation and lead to sterile local symptoms.The association of this incident to inion product is very unlikely, but with the information inion has received cannot be ruled out without a doubt.However, inion has not received any information of this incident that would implicate relevance to the inion device.Post market surveillance data gathered throughout the years of inion freedomscrew implants do not give reason to believe that the incident would be related to the bioabsorbable implant.
Event or Problem Description
Based on the information received by inion, 38 year-old male patient suffering from type 2 diabetes had internal fixation with incision and reduction of right ankle fracture using inion freedomscrew¿ 4.5 x 55 mm, cannulated (osc-4555, lot 2307022).Surgery was performed under general anesthesia, the fracture of fibula was fixed with a bone grafting plate and the lower tibial fibula was fixed with resorbable screws, and the surgery was successfully completed and the patient discharged.1,5 months after the operation redness, swelling, and oozing of fluid appeared in the wound.The patient was admitted to the hospital for debridement, also antibiotics were given to prevent infection.The wound healed and patient was discharged.

• Brand Name: INION FREEDOMSCREW
• 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: 19603677
• Report Number: 3003407235-2024-00002
• Device Sequence Number: 7317655
• Product Code: HWC
• UDI-Device Identifier: 06438408003592
• UDI-Public: 06438408003592
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2024

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: 07/01/2026
• Device Model Number: OSC-4555
• Device Catalogue Number: OSC-4555
• Device Lot Number: 2307022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2023
• 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: ORTHMED FIBULAR BONE PLATE; TITANIUM PINS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male