NA 310.32Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982186492), received between Apr 5, 2018 and Oct 4, 2019 — 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. 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.

• MalfunctionOct 4, 2019Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON PRE DRILLED PINS (SCREWS) WITH A 3.2MM DRILL BIT. THE DRILL BIT GOT STUCK IN THE SECOND HOLE. WE USED THE CUTTING GUIDE AS PLANNED AND THERE WAS NO DELAY TO THE CASE. THERE WAS NO SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TRAUMA SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9158766 ↗
• MalfunctionApr 5, 2018Break; Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2018, THE TIP OF ONE (1) 3.2 MM DRILL BIT BROKE INTO TWO PIECES INSIDE THE BONE AND WAS LATER FOUND AND RETRIEVED. WHILE THE SURGEON WAS USING THE DRILL BIT THROUGH THE CUTTING GUIDE FOR THE KNEE REPLACEMENT, SOMEHOW THE SURGEON FLEXED THE PATIENT'S KNEE AND THE TIP OF THE DRILL BIT BROKE. THE BROKEN TIP WAS FOUND AND RETRIEVED. IT IS UNKNOWN IF ANOTHER DRILL BIT WAS AVAILABLE FOR USE, BUT THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THIS COMPLAINT INVOLVES ONE (1) DEVICE. CONCOMITANT DEVICES REPORTED: UNKNOWN DRILL (PART# UNKNOWN, LOT# UNKNOWN); UNKNOWN KNEE PROSTHESIS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7401637 ↗