Inion FreedomPin™ 1 (REF OPK-15K2)Recalls & reported problems
Inion Oy · Pin kit 1.5 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 06438408012341), received between May 5, 2025 and May 5, 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
- Impaired Healing1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
71-YEAR-OLD FEMALE PATIENT WITH UNDERLYING DISEASES INCLUDING HYPERTENSION GRADE 2, TYPE 2 DIABETES MELLITUS, MILD ANAEMIA, SJÖGREN'S SYNDROME AND PERICARDIAL EFFUSION UNDERWENT INTERNAL FIXATION OPERATION OF A DISPLACED TRIMALLEOLAR ANKLE FRACTURE WITH TWO METAL HOLLOW SCREWS (UNKNOWN MANUFACTURER) AND ONE INION FREEDOMPIN (OPK-15K2, INION FREEDOMPIN¿ KIT Ø1.5 MM) IN (B)(6) 2025. THE PATIENT WAS DISCHARGED SUCCESSFULLY FROM THE HOSPITAL AFTER THE OPERATION. APPROXIMATELY 2 WEEKS LATER THE PATIENT WAS READMITTED TO HOSPITAL DUE TO POOR POSTOPERATIVE WOUND HEALING. DEBRIDEMENT AND REMOVAL OF METAL INTERNAL FIXATION WERE PERFORMED, THE INION FREEDOMPIN WAS LEFT IN PLACE. ACCORDING TO THE INFORMATION RECEIVED, NO BACTERIAL CULTURES WERE TAKEN FROM THE WOUND AND NO ANTIBIOTIC TREATMENT WAS GIVEN. THE WOUND HEALED AFTER DEBRIDEMENT AND METAL FIXATION REMOVAL. THE FRACTURE HAS BEEN HEALING WELL.
Patient problems: Impaired Healing
MAUDE report 21959226 ↗
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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