QUICKSET 2274-57-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 10603295109327), received between Oct 19, 2017 and Aug 13, 2026 — classified as 119 malfunctions.

The most frequently reported specific device problem is “Break” (93 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 25 most recent of 119 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Break

  A drill bit broke due to a mishap used during the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240291 ↗
• MalfunctionJul 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059487 ↗
• MalfunctionJul 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50034644 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT, DURING A TOTAL HIP REPLACEMENT SURGERY, THE REGISTRAR BROKE DRILL BITS WHILE PREPARING FOR AN ACETABULAR SCREW. THE SURGERY WAS NOT DELAYED. THE SURGERY WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED. THE FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WERE NO PATIENT STATUS CHANGES, ADVERSE OUTCOMES, OR CONSEQUENCES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301677 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED A 40MM DRILL BIT BROKE. NO IMPACT TO PATIENT OR DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888293 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THE DRILL BIT BROKE INTO TWO FRAGMENTS DURING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561260 ↗
• MalfunctionMar 10, 2026Break

  DURING THE PROCEDURE, IT WAS OBSERVED THAT WHILE USING THE 40 MM DRILL BIT, IT BROKE DURING THE DRILLING OF THE ACETABULAR CUP. A PROMPT SOLUTION WAS IMPLEMENTED BY REMOVING THE FRAGMENTS OF THE BROKEN DRILL BIT AND REPLACING IT WITH ANOTHER DRILL BIT OF THE SAME SPECIFICATIONS, ALSO INCLUDED IN THE KIT. THIS ALLOWED THE SURGERY TO BE COMPLETED SUCCESSFULLY, WITHOUT ANY ADVERSE EFFECTS ON THE PATIENT OR ALTERATIONS TO THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557876 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT THREE (3) DRILL BITS BROKE INTRAOPERATIVELY. ALL FRAGMENTS WERE RETRIEVED AND NOTHING LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447325 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT THREE (3) DRILL BITS BROKE INTRAOPERATIVELY. ALL FRAGMENTS WERE RETRIEVED AND NOTHING LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447316 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT FRACTURED DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609467 ↗
• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THE DRILL BIT BROKE DURING DRILLING. THE BROKEN BIT WAS REMOVED AND ANOTHER DRILL BIT WAS USED INSTEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584194 ↗
• MalfunctionNov 6, 2025Break; Break

  DURING THE SURGICAL PROCEDURE OF DRILLING THE HOLES FOR THE PLACEMENT OF 6.5 MM ACETABULAR SCREWS, THE QUICKSET 40 MM DRILL BIT WAS BROKEN. THE BIT FRAGMENTS CAME OUT EASILY, WITHOUT CAUSING ANY ADDITIONAL PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487886 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE DRILL BROKE INTO TWO PIECES DURING NORMAL USE. BOTH PIECES WERE RETRIEVED AND DISPOSED OF IN THE SHARPS BIN. A DIFFERENT DRILL FROM THE SAME INSTRUMENT SET WAS USED TO COMPLETE THE SURGERY. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476251 ↗
• MalfunctionOct 16, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT PATIENT UNDERWENT HIP SURGERY ON (B)(6) 2025. THE DRILL GUIDE WAS USED FOR SCREWS IN THE ACETABULAR SHELL AND DRILL BITS KEPT BREAKING. THE GUIDE WAS ALSO GETTING HOT. SURGEON THINKS THE DRILL BITS WERE HITTING ON THE DRILL GUIDE BECAUSE IT WAS WARPED. FRAGMENTS WERE GENERATED BUT ALL REMOVED. NEW DRILL BITS WERE USED. DRILL BITS WERE THROWN OUT BUT NOT THE DRILL GUIDE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23315801 ↗
• MalfunctionSep 17, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED: A. WERE FRAGMENTS GENERATED? IF SO, WERE ALL FRAGMENTS RECOVERED? - IF A FRAGMENT OF THE BIT WAS GENERATED, BUT IT WAS RECOVERED. THE TWO PIECES FRACTURES WERE SENT FROM THE PINNACLE IMPACTOR. B. DID IT BREAK INTO TWO OR MORE PIECES? IF NOT, SPECIFY THE ALLEGED DEFICIENCY OF THE INSTRUMENT. IS IT BENT, CRACKED, WORN OR WITH THE CROSS THREAD? - YES, THE TWO PIECES BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072806 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT THE 40MM DRILL BIT FROM CONSIGNMENT TRAY SNAPPED IN HALF MID OPERATION. THERE WAS NO PATIENT HARM OR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641966 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THE DEVICES WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543116 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS BREAKAGE AND REPAIR OF CONSIGNED ITEMS IN THE ACCOUNT FROM GENERAL USAGE. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532204 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THE DEVICES WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532134 ↗
• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT MULTIPLE DRILL BITS WERE BROKEN DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410793 ↗
• MalfunctionJun 11, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE DRILL BIT WAS BROKEN AT THE TIME OF PUTTING IN THE SCREWS OF THE ACETABULUM. ALL THE PATIENT MATERIAL WAS REMOVED, THERE WAS NO INCIDENT WITH THE PATIENT NOR DID THEY HAVE ANY INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184181 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL WAS BROKEN DURING THE PROCEDURE THERE ARE NO FRAGMENTS REMAINING IN THE PATIENT . THE INSERTION DEVICE WOULD NOT GRAB THE BIT SO IT CAN NOT BE USED.

  Patient problems: Insufficient Information

  MAUDE report 22019773 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT BROKE DURING THE INSERTION OF THE ACETABULAR SCREWS. THE PIECES WERE REMOVED IMMEDIATELY. THERE WAS NO DELAY OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017774 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT THE MODULAR DRILL BIT BROKE DURING PROCEDURE. BOTH BITS WERE REMOVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010899 ↗
• MalfunctionMay 2, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT BROKE INTO TWO PIECES. THE FRAGMENTS WERE REMOVED. NO EFFECT TO PATIENT OR PROCEDURE, APART FROM SLIGHT DELAY OF TWO MINUTES RELOADING DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21951663 ↗