Inion FreedomPin™ 1 (REF OPK-20K2)Recalls & reported problems
Inion Oy · Pin Kit 2.0 mm (2 pcs) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06438408004377), received between Apr 2, 2025 and Apr 2, 2025 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bacterial Infection1
- Post Operative Wound Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A 56-YEAR-OLD FEMALE WITH HYPERTENSION UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF A TIBIA AND FIBULA FRACTURE. BOTH METAL IMPLANTS AND ABSORBABLE INION FREEDOMPINS (INION FREEDOMPIN¿ KIT Ø2.0 MM AND INION FREEDOMPIN¿ KIT Ø1.5 MM (REPORTED SEPARATELY)) WERE USED IN THE FIXATION. THE PATIENT WAS DISCHARGED SUCCESSFULLY. APPROXIMATELY 1 YEAR LATER THE PATIENT WAS RE-ADMITTED TO HOSPITAL WITH POOR WOUND HEALING. BASED ON THE INFORMATION RECEIVED, DESPITE INITIAL WOUND HEALING THE WOUND STARTED TO HAVE SYMPTOMS APPROXIMATELY 10 DAYS PRIOR TO THE RE-ADMISSION TO HOSPITAL (1 YEAR AFTER THE ORIGINAL OPERATION), BACTERIAL CULTURES WERE TAKEN AND BACTERIA WAS FOUND. THE PATIENT WAS TREATED WITH ANTIBIOTICS, DEBRIDEMENT AND INTERNAL FIXATION REMOVAL OF METAL IMPLANTS. THE PATIENT WAS DISCHARGED AFTER WOUND HEALING. THE INION FREEDOMPIN IMPLANTS WERE NOT REMOVED AND BASED ON THE INFORMATION RECEIVED BY INION, THE FRACTURES HAVE HEALED.
Patient problems: Bacterial Infection; Post Operative Wound Infection
MAUDE report 21750901 ↗
Other PIN, FIXATION, SMOOTH devices
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- SMART TOE ST0A-16PStryker GmbH · PIN, FIXATION, SMOOTH1 recall5 reports
- SMART TOE ST0-19PStryker GmbH · PIN, FIXATION, SMOOTH1 recall2 reports
- Flower E-Kit, Advanced EWK 201Flower Orthopedics Corporation · Pin, Fixation, Smooth1 recall0 reports
- Brasseler USA 5007972M0Peter Brasseler Holdings, LLC · PIN, FIXATION, SMOOTH1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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