NA 702626Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540112897), received between Sep 6, 2019 and Aug 9, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2023Break; Fracture; Break; Fracture

  A MEDWATCH REPORT #MW5119133 WAS RECEIVED WHICH INDICATED "K-WIRE BROKE OFF INSIDE THE SCREW DURING PELVIC FRACTURE REPAIR CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17494509 ↗
• MalfunctionSep 6, 2019Break

  AS REPORTED: "TWO K-WIRES BROKE AT BASE OF FLUTES WHILE DRILLING. FRACTURE FIXED BUT DRILL TIPS WERE LEFT IN PATIENT." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 8972810 ↗
• MalfunctionSep 6, 2019Break

  AS REPORTED: "TWO K-WIRES BROKE AT BASE OF FLUTES WHILE DRILLING. FRACTURE FIXED BUT DRILL TIPS WERE LEFT IN PATIENT." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 8972809 ↗