Inion CompressOn™ Instrument 1 (REF IFS-2708)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06438408008061), received between Nov 14, 2025 and Nov 14, 2025 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  DURING A KNEE OCD FIXATION, AFTER THE INSERTION OF THE FIRST K-WIRE, INION DRILL TAP BROKE AT ITS TIP. THIS WAS NOTICED AFTER THE INSERTION OF THE SECOND K-WIRE, WHEN THE DRILL TAP BECAME MORE TIGHTLY STUCK. UPON TAKING THE DRILL TAP OUT, IT WAS DISCOVERED THAT THE K-WIRE HAD BROKEN INSIDE THE BONE. AT THIS POINT THE FIRST K-WIRE WAS ALSO CHECKED (SCREW WAS ALREADY INSERTED) AND IT WAS DISCOVERED THAT THE FIRST K-WIRE HAD ALSO BEEN BROKEN INSIDE THE BONE. THE BROKEN K-WIRE PIECES WERE REMOVED FROM POSTERIOR (POPLITEAL) SIDE, WHICH ADDED 60 MINUTES TO THE OPERATION TIME. A SMALL PIECE OF THE DRILL TAP TIP (APPROXIMATELY 1MM) WAS LEFT INSIDE THE FIRST SCREW TUNNEL. BASED ON SURGEON'S EVALUATION, THE ONLY HARM TO PATIENT CAUSED BY THE INCIDENT WAS AN ADDITIONAL SURGICAL SCAR TO POPLITEAL SIDE. THIS EVENT IS BEING REPORTED AS IT CAUSED APPROXIMATELY A 60-MINUTE DELAY TO OPERATION TIME AND THE REMOVAL OF THE BROKEN K-WIRE PIECES FROM THE POPLITEAL SIDE CAUSED A CHANGE IN THE ORIGINAL OPERATION PLAN AND RESULTED IN AN ADDITIONAL SURGICAL SCAR TO POPLITEAL AREA. ALSO THE INION DRILL TAP BROKE DURING OPERATION AND A SMALL PIECE FROM THE DRILL TAP TIP WAS LEFT INSIDE THE SCREW TUNNEL. NOTE:

  Patient problems: Infiltration into Tissue; Insufficient Information

  MAUDE report 23552040 ↗