MAUDE Adverse Event Report: INION OY INION FREEDOMPIN¿

Model Number	1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Post Operative Wound Infection (2446)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on information provided by the customer, it is probable that the patient's wound healing problems were caused by bacterial infection.The symptoms started shortly after the original operation, bacterial cultures were done from the wound which found bacteria and antibiotics, debridement and flap transfer resulted in wound healing.Bacterial infection is surgery-related risk, and this risk always exists when surgery is being performed, regardless which type of fixation implants are used.Bacteria can enter the body during or after surgery, potentially causing wound infection and biofilm can form on both metallic and biodegradable implants.A recent study by pilskog et al.2023 states that the most common complication after operative treatment of ankle fracture is fracture-related infection (fri, prevalence of 1.44-16%).In their study consisting of 1004 patients, the prevalence of fris was 9% (87/1004 patients), however healthy young patients (18 years of age) had low probability (1%) of developing fri, 50-year-old patients without any risk factors had a 3% probability of developing fri, but this risk doubled if the patient was a smoker (7%).Eighty-year-old patients had an 6% risk of developing fri, while old comorbid patients (>80 years of age with pad) had a very high probability (> 26%) of developing fri after surgical treatment for ankle fractures.The inion implants are provided sterile and the batch record review which was carried out showed that the sterilization dose and dimensional and mechanical properties of the lot to which the implants used in the operations belonged to were within the specification.Blister and pouch seals of the inspected packages passed for the visual inspection.Thus, the bacteria entering the body can be evaluated not to be related to inion implant sterility.Bioabsorbable implants can sometimes cause tissue reactions related to the implant material degradation.However typically implant material degradation related inflammatory tissue reactions occur much later than in this case, i.E., typically 1-2 years postoperatively.In the patient case in question the debridement was carried out approximately 3 weeks after original operation.It should also be noted that in case of implant material degradation related inflammatory tissue reactions, there is no bacteria present.Overall, the implant material degradation related tissue reaction in this case does not seem likely.To conclude, it is probable that the patient's wound healing problems were caused by bacterial infection which is a general surgery-related risk.
Event or Problem Description
A 50-year-old male patient with no underlying diseases underwent open reduction and internal fixation for ankle fracture (left trimalleolar fracture, dislocation and ligament injury).Inion freedompins were used in the fixation together with metal implants.The operation was successful.3 weeks after initial operation the patient was re-admitted to a hospital with postoperative wound infection.Bacterial cultures were taken and bacteria was found.The treatment for the wound infection included antibiotics, debridement and flap transfer.The wound healed after debridement and flap transfer and the patient was discharged.No implant removals were necessary (either metal implants or inion freedompins).The trimalleolar fracture has been healed.

• Brand Name: INION FREEDOMPIN¿
• Common Device Name: PIN
• 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: 21750349
• Report Number: 3003407235-2025-00001
• Device Sequence Number: 8220613
• Product Code: HTY
• UDI-Device Identifier: 06438408004346
• UDI-Public: 06438408004346
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/14/2025

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 Model Number: 1
• Device Catalogue Number: OPK-15K2
• Device Lot Number: 2403021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• 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: METAL IMPLANTS (UNKNOWN MANUFACTURER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male