NA 02.221.112Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982275509), received between Apr 25, 2023 and Apr 25, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/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.

• MalfunctionApr 25, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING ORIF OF RIGHT FEMUR UPON CONNECTING RING ATTACHMENT PLATE TO THE PROXIMAL FEMUR PLATE, THE CONNECTING SCREW ON THE RING ATTACHMENT STRIPPED AND WAS NOT ABLE TO BE DISCONNECTED. THE APPROPRIATE TORQUE LIMITING DRIVER WAS UTILIZED. ANOTHER PLATE AND RING ATTACHMENT WERE CHOSEN AND UTILIZED FOR THE CASE WITH NO ISSUES, DELAYS OR PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) 3.5/4.5MM VA PPFX PROX FEMUR PLATE/7HOLES/RIGHT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808650 ↗