NA 700355Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540413789), received between May 3, 2019 and Aug 5, 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 16, 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.

• MalfunctionAug 5, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147424 ↗
• MalfunctionMay 3, 2019Break; Difficult to Remove

  THE FOLLOWING WAS REPORTED FROM MEDWATCH (MW5085498); "PROCEDURE(S): ORIF LEFT BOTH COLUMN ACETABULUM FRACTURE, ORIF LEFT COMMUNICATED SACRAL FRACTURE VIA OPEN POSTERIOR APPROACH, REMOVAL OF DISTAL FEMORAL TRACTION PH. SURGEONS USED STRYKER DRILL BIT WHEN IT BROKE OFF IN THE PT'S BONE (ILIUM). IT WAS ESTIMATED THAT APPROX. 2 CM REMAIN IN THE PT. SURGEONS WERE UNABLE TO RETRIEVE IT." NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8579694 ↗