611 - ANKLE FUSION NAIL LJU601Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700386938276), received between Feb 20, 2019 and Oct 11, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Eject” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A NAIL REMOVAL DUE TO JOINT FUSION DID NOT OCCUR, PERSISTENT PAIN IN THE PATIENT. DURING REMOVAL THE 2 ANTEROPOSTERIOR SCREWS BROKE. HALF OF THE SCREW REMAINED IN THE POSTERIOR PART OF THE CALCANEUS AS WELL AS IN THE LOCKING HOLE OF THE NAIL MAKING IT VERY COMPLICATED TO REMOVE THE NAIL. LENGTHENING OF MORE THAN 2 HOURS THE DURATION OF THE INTERVENTION. THE 2 PIECES OF SCREW COULD NOT BE REMOVED AND WERE THEREFORE LEFT IN THE PATIENT'S CALCANEUM. THE SURGEON WAS FORCED TO USE THE SLEDGEHAMMER TO AVOID A NEW POSTERIOR APPROACH, WHICH COULD HAVE FURTHER WEAKENED THE PATIENT'S CALCANEUS.

  Patient problems: Foreign Body In Patient; Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 15584657 ↗
• MalfunctionFeb 20, 2019Failure to Eject; Failure to Eject

  DURING A SURGERY IN ORDER TO REMOVE A NAIL AT THE ANKLE, THE SURGEON NOTICES THAT ONE OF THE SCREWS LOCKING THE NAIL SEEMS "WELDED". THE SURGEON WAS UNABLE TO PERFORM THE PLANNED OPERATION AND HAD TO PERFORM A TIBIA OSTEOTOMY REQUIRING AN ADDITIONAL SURGICAL APPROACH AS WELL AS AN INCREASED DURATION OF OPERATION.

  Patient problems: No Information

  MAUDE report 8354126 ↗