Inion CompressOn™ Instrument 1 (REF IFS-9063)Recalls & reported problems
Inion Oy · K-wire Ø 0.8x150 mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06438408008917), received between Feb 4, 2026 and Feb 4, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Material Split, Cut or Torn1
Patient problems
- Infiltration into Tissue1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2026Fracture; Material Split, Cut or Torn
AN OSTEOCHONDRAL TALUS FRACTURE WAS FIXED WITH 2.7 MM INION COMPRESSION SCREWS. AFTER SUCCESSFUL FIXATION OF THE FRACTURE FRAGMENT, A FLUOROSCOPY WAS TAKEN PRIOR TO WOUND CLOSURE. THE PICTURE REVEALED THAT THE 0.8 MM INION K-WIRE USED HAD BROKEN DURING THE OPERATION AND AN APPROXIMATELY 26 MM K-WIRE FRAGMENT REMAINED INSIDE THE TALUS BONE. THE SURGEONS DECIDED TO CLOSE THE SURGICAL WOUND AND TAKE A CT THE FOLLOWING DAY TO EVALUATE IF REOPERATION IS NEEDED TO REMOVE THE K-WIRE FRAGMENT. NO IMMEDIATE HARM OR CLINICAL DETERIORATION WAS OBSERVED. THE PATIENT UNDERWENT THE CT SCAN THE FOLLOWING DAY WHERE IT WAS EVALUATED THAT THE K-WIRE PASSES THROUGH THE BONE, BUT DOES NOT ENTER TO THE SUBTALAR JOINT, SO NO INTERVENTION WERE REQUIRED. CURRENTLY THE FRAGMENT DOES NOT CAUSE CLINICAL SYMPTOMS TO THE PATIENT. THIS INCIDENT IS CONSIDERED A MALFUNCTION AS THE K-WIRE BROKE UNEXPECTEDLY DURING OPERATION AND A FRAGMENT OF THE K-WIRE WAS LEFT INSIDE THE PATIENT. CURRENTLY THIS INCIDENT DOES NOT CAUSE CLINICAL SYMPTOMS TO THE PATIENT, NO CHANGE IN THE SURGICAL PLAN WAS IMPLEMENTED, THERE WAS NO DELAY IN OPERATION AND NO REOPERATION WAS DEEMED NECESSARY AT THIS POINT. THE FIXATION OF THE ACTUAL OS
Patient problems: Infiltration into Tissue; No Clinical Signs, Symptoms or Conditions
MAUDE report 24255865 ↗
Other Guide, Surgical, Instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page