NA 212.211Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982152183), received between Nov 19, 2018 and Sep 15, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Device-Device Incompatibility

  It was reported that there was frequent issues getting 2.4mm locking screws to engage near cortex. Customer did not specify any particular screw length, but thinks it happens with all lengths that customer uses.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773928 ↗
• MalfunctionSep 15, 2026Device-Device Incompatibility

  It was reported that there was frequent issues getting 2.4mm locking screws to engage near cortex. Customer did not specify any particular screw length, but thinks it happens with all lengths that customer uses.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773897 ↗
• InjuryNov 19, 2018Break; Break

  IT WAS REPORTED THAT ON OCTOBER 31, 2018, THE PATIENT UNDERWENT A PLATE REMOVAL BECAUSE OF THE BROKEN 4.5MM CURVED BROAD LOCKING COMPRESSION PLATE. THERE WAS A SURGERY TO REPAIR THE NON-UNION OF THE FRACTURE. PATIENT REQUIRED ADDITIONAL INTERVENTION BECAUSE THE ORIGINAL FRACTURE HAD NOT YET HEALED WHEN THE BROKEN PLATE WAS REMOVED, DOCTOR IMPLANTED AN ANTEGRADE FEMORAL NAIL. SURGICAL DELAY IS UNKNOWN. PROCEDURE OUTCOME WAS SUCCESSFUL. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: LOCKING SCREWS (PART/LOT UNKNOWN, QUANTITY 11).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8085718 ↗