NA 212.820Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982152879), received between Jul 2, 2021 and Sep 15, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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. 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 6 most recent of 6 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 50773721 ↗
• 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 50773678 ↗
• 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 50773662 ↗
• 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 50773627 ↗
• InjuryJun 23, 2025Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT FELL OFF HER BIKE. SHE SUSTAINED A LEFT POSTEROLATERAL ELBOW DISLOCATION AND OTHER INJURIES. ON (B)(6), 2024 THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF A CLOSED DISPLACED FRACTURE OF THE RADIAL HEAD/NECK, PRIMARY REPAIR OF LATERAL ULNAR COLLATERAL LIGAMENT USING LOCAL TISSUE, AND OPEN TREATMENT OF THE ELBOW DISLOCATION. A RADIAL HEAD FRACTURE FRAGMENT WAS EXCISED AND THE REMAINING RADIAL HEAD WAS ANATOMICALLY REDUCED AND STABILIZED USING A 2.4MM LOCKING COMPRESSION PLATE. THE LATERAL ULNAR COLLATERAL LIGAMENT WAS REPAIRED USING A METAL ANCHOR AND FIBERWIRE. THE PROCEDURE WAS UNSUCCESSFUL IT SOUNDS LIKE A FAILURE OF THE HARDWARE. A CT SCAN ON (B)(6), 2025 REVEALED THAT SOME VOLAR FRAGMENTS NOT INCLUDED IN THE FIXATION APPEARED INCREASINGLY DISPLACED. THERE WAS ALSO CONCERNED FOR POSSIBLE LOOSENING OR INFECTION AT THE LATERAL EPICONDYLE ANCHOR, ALONG WITH SMALL BONY FRAGMENTS IN THE POSTEROLATERAL ELBOW. (B)(4).

  Patient problems: Fatigue; Insufficient Information; Pain

  MAUDE report 22309356 ↗
• MalfunctionJul 2, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE SEALED PACKAGE OF THE SCREW WAS DELIVERED EMPTY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 20MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12109873 ↗