NA 1806-3540SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540196613), received between Feb 21, 2019 and Dec 14, 2022 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 14, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE DRILL BROKE.

  Patient problems: Insufficient Information

  MAUDE report 15982815 ↗
• MalfunctionOct 12, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS DOING A T2 HUMERAL NAIL AND THAT, WHILE PERFORMING THE PROXIMAL LOCKING, AFTER INSERTING A OBLIQUE SCREW, AN ATTEMPT TO DRILL A PROXIMAL TRANSVERSE SCREW WAS DONE AND THE DRILL BIT SEEMED TO HAVE BROKEN. THE PIECE REMAINS IN THE HUMERAL HEAD. NO FURTHER EFFORT WAS MADE TO RETRIEVE AND THERE WAS NO ADVERSE CONSEQUENCE OR EXTENDED OR TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 15588688 ↗
• MalfunctionFeb 21, 2019Break

  MAUDE REPORT (MW5082498) WAS RECEIVED BY STRYKER AND REVIEWED FOR THE FOLLOWING EVENT: PATIENT IN SURGERY FOR TOTAL HIP REPLACEMENT. A STRYKER DISPOSABLE DRILL BIT BROKE OFF DURING THE SURGERY. BROKEN PIECE RETRIEVED AND APPEARED TO BE INTACT. SURGEON AWARE. NEW DRILL BIT OBTAINED, AND SURGERY CONTINUED. NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8359056 ↗