NA 2274-20-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295109105), received between Jul 16, 2019 and Feb 20, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Nonstandard Device; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY THE DRILL BIT HOLDER COULD NOT BE MOUNTED TO INSERT THE SCREW. THE HOLDER USED A DIFFERENT ANCHORING MECHANISM THAN THE DRILL BITS ON THE MACHINE, WHICH DISPLEASED THE SPECIALIST. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT AFFECTING THE PATIENT. THE SPECIALIST WAS VERY DISSATISFIED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402901 ↗
• MalfunctionJul 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE LEFT PRIMARY TOTAL HIP SCREWDRIVER HANDLE RATCHET MECHANISM WOULD NOT WORK PROPERLY. FLEXIBLE DRILL SHAFT WAS DIFFICULT TO INSERT DRILL BIT. CASE WAS FINISHED WITHOUT ANY ISSUES. NO EXTENDED SURGICAL TIME OR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642343 ↗
• MalfunctionJul 7, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS UNABLE TO LOAD THE DRILL BIT INTO THE FLEXIBLE DRILL SHAFT. IT WASN'T NEEDED FOR THE CASE, SO NO ACTION WAS REQUIRED. NO DELAY OR EXTENDED SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22422032 ↗
• MalfunctionMay 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A DRILL SHAFT WAS DAMAGED DURING A PROCEDURE. THE DRILL SHAFT WAS NO LONGER LOCKING ONTO THE DRILL BIT. WEAR AND TEAR WAS SUSPECTED. AN ALTERNATIVE FLEX DRILL SHAFT WAS USED AND DRILL BIT LOCKED INTO PLACE WITH NO ISSUES. THERE WAS NO DELAY TO SURGERY. THERE WAS NO IMPACT ON THE PATIENT. THE DRILL SHAFT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061155 ↗
• MalfunctionFeb 21, 2023Break; Break

  IT WAS REPORTED THE FLEXI SHAFT ON THE PINNACLE SCREW DRIVER IS BROKEN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16408936 ↗
• MalfunctionSep 29, 2022Break; Break

  IT WAS REPORTED THE DRILL SHAFT HANDLE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501220 ↗
• MalfunctionJan 27, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE INSTRUMENTS ARE BLUNT. DIDN¿T ADD ANYTIME ON TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13368158 ↗
• MalfunctionJan 27, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE INSTRUMENTS ARE BLUNT. DIDN¿T ADD ANYTIME ON TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13368138 ↗
• MalfunctionDec 7, 2021Break; Break

  BROKEN DRILL BIT IN FIFE THEATRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12955740 ↗
• MalfunctionJan 6, 2021Break; Material Deformation; Break; Material Deformation

  PLEASE CLARIFY WHAT DO YOU MEAN BY CRASHED. WAS IT BROKEN OR CRACKED?: ANSWER: IT WAS REPORTED THAT IT WAS FLATTED.

  Patient problems: Insufficient Information

  MAUDE report 11126042 ↗
• MalfunctionNov 13, 2020Device-Device Incompatibility; Device-Device Incompatibility

  FLEXIBLE DRILL CHUCK WOULD NOT HOLD DRILL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10835977 ↗
• MalfunctionJul 16, 2019Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER HANDLE AND DRILL BIT HOLDER WERE BROKEN. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8795460 ↗