BALL HEX DRIVER, CANNULATED 0494Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665013467), received between Apr 26, 2023 and Apr 26, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2023Break; Break

  ON 03/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A SCREW CROSS THREADED AND STRIPPED THE THREADS ON BOTH AN 1239-100 INSERTION GUIDE, AND A 1255-300 TIBIAL INSERTION GUIDE. IN ATTEMPTS TO RETRIEVE IT (2) 0494-000 BALL HEX DRIVER BROKE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815469 ↗
• MalfunctionApr 26, 2023Break; Break

  ON 03/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A SCREW CROSS THREADED AND STRIPPED THE THREADS ON BOTH AN 1239-100 INSERTION GUIDE, AND A 1255-300 TIBIAL INSERTION GUIDE. IN ATTEMPTS TO RETRIEVE IT (2) 0494-000 BALL HEX DRIVER BROKE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815461 ↗