NA 205.044Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982146915), received between Apr 19, 2018 and Apr 19, 2018 — classified as 1 injury.

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

• InjuryApr 19, 2018Bent; Loose or Intermittent Connection; Bent; Loose or Intermittent Connection

  IT WAS REPORTED BY ARGENTINA THAT A PATIENT UNDERWENT AN ANTECEDENT OSTEOSYNTHESIS OF TIBIA (KNEE JOINT) BY LCA AVULSION IN 2012 WITH TWO (2) 3.5MM CANNULATED SCREWS. PATIENT HAD REVISION SURGERY ON (B)(6) 2017 DUE TO LOOSENING OF PAINFUL OSTEOSYNTHESIS. THE PATIENT HAD SOME PAIN IN HIS KNEE. AN X-RAY TAKEN ON AN UNKNOWN DATE SHOWED ONE OF THE SCREWS TURNED INTO THE JOINT (LOOSE SCREW) AND THE OTHER SCREW WAS BENT. MOVEMENT OF THE LOOSE SCREW CAUSED DAMAGE TO THE FEMORAL CARTILAGE AND SURGEON DECIDED TO REMOVE BOTH SCREWS. THE LOOSE SCREW WAS COMPLETELY REMOVED. THE LOOSE SCREW DID NOT BREAK DURING REMOVAL AND THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. THE SECOND SCREW WAS BENT PRIOR TO REMOVAL. INITIALLY THE SURGEON TRIED USING THE SCREWDRIVER BUT WAS UNABLE TO REMOVE THE SCREW IN ITS BENT STATE AND A FORCE CLAMP WAS USED FOR REMOVAL AND IN THAT MOMENT THE HEAD OF THE SCREW BROKE. THERE WERE NO FRAGMENTS FROM THE SECOND SCREW BECAUSE A FORCE CLAMP WAS USED. BOTH SCREWS WERE COMPLETED REMOVED. PATIENT WAS NOT REVISED TO ANY ADDITIONAL HARDWARE, AS THE FRACTURE HAD CONSOLIDATED. BOTH SCREWS ARE AVAILABLE FOR RETURN. IT IS UNKNOWN AS TO WHICH SCREW WAS LOOSE AND WHICH SCREW WAS BEN

  Patient problems: Failure of Implant

  MAUDE report 7444239 ↗