NA 04.211.040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982119124), received between Jan 9, 2024 and May 8, 2026 — classified as 2 malfunctions.

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

• MalfunctionMay 8, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY FOR DISTAL HUMERUS FRACTURE WITH PLATES AND SCREWS. DURING SURGERY, AFTER USING TWO PLATES TO FIX THE FRACTURE, THE IMAGE SHOWED THAT THE INNER PLATE WAS MISALIGNED. AFTER REMOVING THE PROXIMAL SCREWS, THE PLATE POSITION WAS FINELY ADJUSTED AND THEN REINSTALLED WITH CORTEX SCREWS. DURING THAT PROCESS, THE TWO DISTAL SCREWS IN QUESTION THAT HAD NOT BEEN REMOVED BROKE OFF BELOW THE SCREW HEADS. THE SURGEON REMOVED THE PLATE, PULLED OUT THOSE TWO SCREWS WITH HERCULES PLIERS, AND THEN REINSTALLED THE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINUTES SURGICAL DELAY. THE SURGEON COMMENTED THAT THIS EVENT WAS CAUSED BY EXCESSIVE STRESS TO THE SCREWS BY FORCING THE PLATE INTO PLACE DURING REINSTALLATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25123559 ↗
• MalfunctionJan 9, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON DECEMBER 14, 2023, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH PLATE AND LOCKING SCREWS FOR A RIGHT OLECRANON FRACTURE. FINAL LOCKING OF THE LOCKING SCREWS WAS PERFORMED AFTER ALL THE SCREWS WERE INSERTED. THE LOCKING SCREW HEAD WAS SPINNING IDLE IN THE HOLE AND COULD NOT BE TIGHTENED. THE LOCKING SCREW IN QUESTION WAS INSERTED IN VARIABLE ANGLE (VA) MODE. IMAGING SHOWED THAT THE LOCKING SCREW SLIGHTLY INTERFERED WITH ANOTHER LOCKING SCREW WHICH WAS INSERTED INTO THE DIAPHYSIS. THIS OTHER LOCKING SCREW WAS FULLY TIGHTENED. ALTHOUGH THE SURGEON ATTEMPTED TO REMOVE THE LOCKING SCREW IN QUESTION TO REPLACE WITH A SHORTER LOCKING SCREW, IT KEPT SPINNING AND COULD NOT BE REMOVED. THEREFORE, THE LOCKING SCREW REMAINED IN THE BODY. THE SURGEON DETERMINED THAT THERE WAS NO PROBLEM WITH THE OVERALL FIXATION AND ADDITIONAL SCREWS WERE NOT INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT WAS STABLE. THERE IS NO PLAN AT THIS TIME FOR IMPLANT REMOVAL AFTER BONE UNION. THE SALES REPRESENTATIVE INFORMED THE SURGEON THAT THE SCREW HEAD HAS STRIPPED AND MIGHT BE DIFFICULT TO R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476397 ↗