NA 702453Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540112064), received between May 2, 2024 and May 2, 2024 — classified as 1 injury.

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

• InjuryMay 2, 2024Break; Fracture; Break; Fracture

  THE FOLLOWING MAUDE REPORT #MW5153440 WAS RECEIVED AND INDICATED THE FOLLOWING: "PATIENT SCHEDULED FOR OPEN REDUCTION INTERNAL FIXATION RIGHT TIBIAL TUBERCLE FRACTURE. THE PATELLA TENDON WAS REINFORCED WITH SEMI-BENNEL SUTURES THROUGH THE LENGTH OF THE PATELLA TENDON AND PASSED THROUGH DRILL HOLES IN THE CORTEX OF THE DISTAL TIBIA SHAFT. DRILL BIT BROKE AND FRAGMENT OF DRILL BIT STUCK IN TIBIAL CORTEX AND WAS NOT RETRIEVABLE. ON (B)(6) 2024 PATIENT SCHEDULED FOR RETRIEVAL OF BROKEN DRILL BIT. THE DRILL BIT TIP WAS LOCATED AND REMOVED".

  Patient problems: Insufficient Information

  MAUDE report 19235109 ↗