Compaction 7209446Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010468581), received between Jan 9, 2018 and Jan 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Split” (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.

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.

• MalfunctionJan 9, 2018Split

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE. DURING THE INSERTION OF THE BONE BLOCK FROM THE GRAFT INTO THE FEMORAL TUNNEL THAT THE BONE BLOCK SPLIT LONGITUDINALLY. GRAFT HAD TO REMOVED FULLY FROM THE KNEE SO THE PIECE OF BONE COULD BE EXCISED, GRAFT THEN PASSED THROUGH BOTH TUNNELS WITH EASE. TUNNELS WERE PREPARED AND SMOOTHED APPROPRIATELY AND NO IMPINGEMENT AT THE TUNNELS WERE OBSERVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7174323 ↗