NA 71563436Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010573261), received between Dec 9, 2019 and May 22, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT, DURING PFJ SURGERY, ONE (1) 4.8 MM QUICK CONNECT DRILL BIT WAS PLACED IN THE WRONG HOLE OF THE JOURNEY PFJ IM DRILL GUIDE, IT COLD WELDED CAUSING THE DEVICE TO SNAPBACK AGAINST THE SURGEON AND THE DRILL BIT BROKE. ALL PARTS WERE RECOVERED. ALSO, ONE (1) MINI CONNECTOR WAS FAULTY, NOT LOCKING THE DRILL FULLY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069393 ↗
• MalfunctionMar 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A PATELLOFEMORAL REPLACEMENT (PFJ) SURGERY, ONE (1) 4.8 MM QUICK CONNECT DRILL BIT FRACTURED AT THE CONNECTOR END AFTER COMPLETELY DRILLING THE HOLE. DEVICE WAS CONNECTED TO A CHUCK TO REMOVE IT. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514598 ↗
• MalfunctionFeb 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING DRILLING IN A PFJ SURGERY, ONE (1) 4.8 MM QUICK CONNECT DRILL BIT SNAPPED IN TWO. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413071 ↗
• MalfunctionDec 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A 4.8 MM QUICK CONNECT DRILL BIT BROKE OFF IN FEMUR. ALL PIECES WERE RETRIEVED. SURGERY WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SN BACK-UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087828 ↗
• InjuryDec 9, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, A 4.8 MM QUICK CONNECT DRILL BIT SNAPPED OFF IN FEMORAL CANAL. THE DEVICE WAS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS DELAYED FOR GREATER THAN 30 MINUTES. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12972391 ↗
• MalfunctionAug 25, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A PFA SURGERY, A 4.8 MM QUICK CONNECT DRILL BIT BECAME STUCK IN THE MINI CONNECTOR. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367641 ↗
• MalfunctionDec 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY, 4.8 MM DRILL SEEMED TO ¿CATCH¿ IN THE BONE WHEN DRILLING THE FEMUR AND CAUSED THE POWER TOOL TO ALMOST FLIP OUT OF THE SURGEON¿S HAND. AS A RESULT, THE CONNECTING END OF THE DRILL BIT WAS SEVERELY TWISTED. NO DELAY. NO BACKUP DEVICE AVAILABLE. NO INJURY OR IMPACT TO PATIENT REPORTED.

  Patient problems: No Information

  MAUDE report 9440689 ↗