QUICKSET 2274-52-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 10603295109273), received between Jul 11, 2017 and Jun 18, 2026 — classified as 3 injuries, 183 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (94 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 25 most recent of 186 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT. THE FLEX DRILL SHAFT WAS NOT ABLE TO CONNECT THE DRILL BIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25547404 ↗
• MalfunctionJun 9, 2026Material Deformation

  IT WAS REPORTED THE DEVICES WERE DAMAGED INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444231 ↗
• MalfunctionFeb 12, 2026Break

  DEVICE SNAPPED AFTER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323178 ↗
• MalfunctionJan 23, 2026Break

  IT WAS REPORTED THAT POST SURGERY, THE DEVICE WAS BROKEN FROM WEAR AND TEAR. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Insufficient Information

  MAUDE report 24172924 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT SURGERY WITH THE PRODUCT IN QUESTION. DUE TO THE EMERGENCY SURGERY, THE PRODUCT FROM OTHER FACILITY WAS USED INSTEAD. DURING THE SURGERY, THE PRODUCT WAS USED AND BROKE BECAUSE THE ACETABULUM BONE WAS HARD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY BY USING ANOTHER AVAILABLE SET OF EQUIPMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24024213 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT THA WITH THE DRILL SHAFT. DURING SURGERY, THE DRILL SHAFT BROKE WHEN THE SURGEON TRIED TO DRILL THE ACETABULAR ROOF. THE SURGEON USED ANOTHER DRILL SHAFT INSTEAD OF THE ONE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815680 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT THE SCREW RETRACTOR IS BROKEN. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016924 ↗
• MalfunctionSep 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE PLACEMENT OF SCREWS FOR ACETABULAR CUP FIXATION, WHEN USING THE DRILL BIT TO MAKE THE HOLES, THE FLEXIBLE HANDLE ALLOWS THE HOLES TO BE MADE, IT DOES NOT REMAIN STABLE WHEN APPLYING PRESSURE AND ACTIVATING THE MOTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963579 ↗
• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A THA SURGERY FOR OA ON ACETABULUM WITH THE PRODUCT IN QUESTION. IN THE SURGERY, WHEN USING THE PRODUCT, SOME MALFUNCTIONS WERE FOUND, BUT IT WAS POSSIBLE TO USE IT WITHOUT ANY PROBLEMS. AFTER THE SURGERY, SIGNS OF THE WIRE COMING OFF WERE FOUND ON THE SHAFT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER DETAILS ON THE TYPE OF MALFUNCTION NOTICED DURING SURGERY WERE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826285 ↗
• MalfunctionAug 11, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A BROKEN PINNACLE FLEXIBLE SCREW SHAFT DURING SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770020 ↗
• MalfunctionJul 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION IT WAS IDENTIFIED THAT THE DEVICE WILL NOT ACCEPT DRILL BIT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22678263 ↗
• MalfunctionJun 30, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT QUICKSET FLEX DRILL SHAFT QUICK COUPLING WAS NO LONGER LOCKING IN PLACE DUE TO INTERNAL FAULT. THERE WAS NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365447 ↗
• MalfunctionJun 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE PROCEDURE, AT THE TIME OF MAKING THE CUP HOLES, TWO 6.5 X 25 ACETABULAR SCREWS WERE PASSED BUT ONLY ONE COULD BE PLACED BECAUSE WHEN PLACING THE SECOND SCREW IN THE PIECE IN WHICH THE BIT IS PLACED (FLEXIBLE HANDLE), WHEN HAVING CONTACT WITH THE BONE, THE BIT WAS REMOVED AND DID NOT ALLOW TO PLACE THE SCREW. FOR THE AFOREMENTIONED THERE WAS DISCOMFORT ON THE PART OF THE SPECIALIST SINCE THE PIECE WHERE THE BIT IS PLACED (FLEXIBLE HANDLE) AND THE BIT WERE NOT WORKING WELL, SO HE DECIDED TO LEAVE ONLY ONE SCREW AND NOT PLACE THE OTHER, THUS MANAGING TO FINISH THE SURGERY SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337957 ↗
• MalfunctionJun 18, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THE FLEXIBLE DRILL HOLDER DRILL BROKE OFF; THE REST IS STUCK. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286539 ↗
• MalfunctionJun 7, 2025Structural Problem; Device-Device Incompatibility; Structural Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FLEXIBLE DRILL SHAFT LOCKING MECHANISM IS NO LONGER WORKING, THEREFORE CANNOT ATTACH DRILL BIT. THIS WAS NOTICED IN SURGERY AND A SECOND SET WAS AVAILABLE, THEREFORE THERE WAS NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162310 ↗
• MalfunctionJun 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DRILL BIT WAS MISSING AND SECOND DRILL BIT BROKE DURING CASE. DIFFICULT IN LATCHING THE FLEXIBLE DRILL SHAFT. THE CALCAR PLANER WAS BLUNT. 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 22132071 ↗
• MalfunctionMay 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

  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 22019859 ↗
• MalfunctionMay 6, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE MARKINGS WERE WORN OFF AND DRILL BIT KEEPS COMING LOOSE. THE SURGERY WAS NOT DELAYED AND IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970373 ↗
• MalfunctionMay 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A FAULTY INSTRUMENT UPON INSPECTION PRE OP. DRILL BIT NO LONGER LOCKING INTO FLEXY DRILL COUPLER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943266 ↗
• MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON IS HAVING ISSUES WITH THE CORAIL/PINNACLE DRILL BITS AND FLEXIBLE DRILL SHAFT CONSTANTLY DETACHING FROM EACH OTHER MID CASE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919914 ↗
• MalfunctionApr 24, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. THE FLEXIBLE DRILL SHAFT LOCKING MECHANISM WAS NOT LOCKING. THIS APPEARS TO BE A RECURRING FAILURE MECHANISM FOR THIS INSTRUMENT. IT WAS IDENTIFIED TO NOT BE USER ERROR NOR THE DRILL BIT AS IT WORKED ON THE RIGID DRILL SHAFT AND ANOTHER FLEXIBLE DRILL SHAFT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899561 ↗
• MalfunctionApr 21, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT THERE WAS A DAMAGED LOCKING MECHANISM ON THE DEVICE POSTOPERATIVELY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873800 ↗
• MalfunctionApr 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE BROCADE IN THE ACETABULUM, THE DRILL BIT COMES OUT OF THE FLEXIBLE DRILL HANDLE. THREE BITS ARE CHANGED AND NOT ATTACHED.

  Patient problems: Insufficient Information

  MAUDE report 21857351 ↗
• MalfunctionFeb 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE NO PATIENT HARM. THEY HAD SPARE OPTIONS ON THE TRAY. THIS EVENT OCCURRED DURING INTRA-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468255 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, WHEN THE SPECIALIST WAS FIXING THE ACETABULAR CUP WITH SCREWS, THE HANDLE OF THE FLEXIBLE DRILL BIT BROKE. IT WAS CAREFULLY CHECKED AND NO FRAGMENTS WERE LEFT IN THE PATIENT. A PROMPT SOLUTION WAS GIVEN USING ANOTHER FLEXIBLE DRILL BIT HANDLE THAT WAS ALSO INCLUDED IN THE EQUIPMENT, THUS SUCCESSFULLY COMPLETING THE SURGERY, WITHOUT CAUSING DISCOMFORT TO THE SPECIALIST, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252377 ↗