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

Model Number	OSA-3545
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In the above discussed case, the problem was most likely caused by the bacterial infection, not by the biodegradable implants (i.E., the patient experienced bacterial infection, not inflammatory reaction caused by the used implants).The timing of the infection would speak in favor of bacterial infection.Bacterial infections typically occur during the first weeks after the operation (just like in this case), whereas the implant material degradation related tissue reactions are sterile fluid accumulations typically seen first much later when the biodegradable implants start to degrade (typically 1-2 years postoperatively in case of the inion freedom implants).Additionally, based on the incident report received by inion, the cause of the incident was analysed in the report as the patient's own reasons, mostly considering the decrease in body resistance after surgery.This would also implicate towards bacterial infection origin of the symptoms.Results of bacterial cultures from samples taken during e.G.Debridement procedures (general bacteria culture and anaerobic bacteria culture) could confirm the presence of bacteria.If antibiotics have been given it may however be difficult to get the bacteria grow properly in the cultures.Bacterial infection is surgery-related risk, and this risk always exists when surgery is being performed, regardless which type of fixation implants are used.The implantation site may be exposed to microbes both intraoperatively or postoperatively during wound healing period.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 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 fluid accumulations.The relevance 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 in any way 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
Bioabsorbable inion freedomscrew (3.5 x 45 mm, ref osa -3545) was used in a right ankle fracture operation on (b)(6), 2023 on a 29-year old male patient.The patient suffered a sprain from playing football resulting in a swollen and painful right ankle, and went to the hospital where an x-ray examination showed an interruption in the bony continuity of the right ankle joint.The right lateral ankle was fixed with a kingstar locking plate (titanium alloy), and the separated lower tibiofibular joint was fixed with one inion freedomscrew.Based on the information received by inion, the fracture was satisfactorily repositioned with a balanced joint space and solidly fixed on fluoroscopy during the operation.10 days after operation ((b)(6), 2023), the wound became infected.A debridement was performed to the wound.Inion has not received information whether bacterial samples were taken from the patient and if antibiotic treatment was given.The patient was discharged from the hospital after debridement.

• 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: 18063123
• Report Number: 3003407235-2023-00009
• Device Sequence Number: 15328425
• Product Code: HWC
• UDI-Device Identifier: 06438408003301
• UDI-Public: 06438408003301
• 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): 11/01/2023

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: 01/01/2026
• Device Model Number: OSA-3545
• Device Catalogue Number: OSA-3545
• Device Lot Number: 2301009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: KINGSTAR LOCKING PLATE (TITANIUM ALLOY).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male