N/A 00-8790-007-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00889024277014), received between Mar 5, 2024 and May 20, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Fracture

  IT WAS REPORTED THAT A SCREWDRIVER BROKE AT THE SPRING. THERE WAS NO PATIENT INVOLVEMENT. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25236316 ↗
• MalfunctionDec 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FLEXIBLE DRILL BIT ATTACHMENT BROKE AT THE SPRING AREA. NO PARTS FELL INTO THE PATIENT, AND ANOTHER ATTACHMENT FROM THE KIT WAS USED TO COMPLETE THE CASE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694960 ↗
• MalfunctionNov 19, 2025Fracture; Fracture

  NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598780 ↗
• MalfunctionOct 16, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23314874 ↗
• MalfunctionAug 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A HIP PROCEDURE THE FLEXIBLE SHAFT BROKEN OFF DRILLING FOR SCREWS. NO HARM PATIENT WAS REPORTED. DUE DILIGENCE IS IN PROCESS AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873046 ↗
• MalfunctionMay 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS OBSERVED THAT THE FLEXIBLE SHAFT BROKE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053524 ↗
• MalfunctionApr 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT TWO DRILL SHAFTS WERE BROKEN DURING THE PROCEDURE, AN IDENTICAL INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT AND ALL DEBRIS WERE RECOVERED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738813 ↗
• MalfunctionNov 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DOCTOR WAS DRILLING THROUGH THE CUP INTO THE ACETABULUM AND THE DRILL SHEARED INTO TWO PIECES. THERE WAS NO IMPACT ON THE PATIENT OR THE SURGERY. NO DELAY WAS CAUSED. BOTH PIECES WERE REMOVED WITHIN A MATTER OF SECONDS AND SURGERY CONTINUED AS USUAL. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788143 ↗
• MalfunctionOct 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THE FLEXIBLE DRILL SHAFT BROKE WHILE DRILLING FOR A SCREW. THERE IS NO REPORTED HARM OR INJURY TO THE PATIENT. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20357870 ↗
• MalfunctionSep 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE MODULAR FLEX SHAFT BROKE IN TWO PIECES WHILE ACCESSING THE CUP. NOTHING FELT INTO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310714 ↗
• InjuryJul 12, 2024Fracture; Fracture

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19730429 ↗
• MalfunctionMay 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE CONTINUUM FLEXIBLE DRILL SHAFT BROKE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS REQUIRED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311297 ↗
• MalfunctionMar 11, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874902 ↗
• MalfunctionMar 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE FLEX SHAFT BROKE DURING THE SURGERY, NO PIECE OR FOREIGN BODY FELL INTO THE PATIENT. THERE IS NO REPORTED HARM OR INJURY TO THE PATIENT. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836178 ↗