QUICKSET 2274-48-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295109242), received between Jun 18, 2018 and May 17, 2024 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2024Break; Break

  TIP OF THE SCREWDRIVER BROKE OFF UPON REMOVING IT FROM THE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339716 ↗
• MalfunctionDec 28, 2023Break; Break

  FLEXIBLE SCREW SHAFT IS BROKEN . THE LOCKING MECHANISM DOES NOT WORK. DRILL BITS CANNOT BE ATTACHED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? -UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN, (B)(6). DEVICE PROPERTY OF? NONE, DEVICE IN POSSESSION OF? NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409390 ↗
• MalfunctionAug 29, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE QUICKSET TAPER HEX SCDR FLEX BROKE. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641861 ↗
• MalfunctionJan 4, 2023Naturally Worn; Naturally Worn

  SCREWDRIVER IS STRIPPED. NO REPORTED SURGICAL DELAY OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096479 ↗
• MalfunctionSep 29, 2022Break; Break

  IT WAS REPORTED THE SCREWDRIVER BROKE DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501492 ↗
• MalfunctionFeb 11, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE 25 DRILL BIT BENT; ARTICULATING SCREWDRIVER TIP BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515012 ↗
• MalfunctionOct 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THE FLEXIBLE SCREWDRIVER SHAFT ON THE PINNACLE SCREW TRAY IS NO LONGER WORKING. THE DRILL PIECE CONTINUED TO FALL OUT OF THE FLEXIBLE SCREWDRIVER SHAFT WHEN THE DEVICE WAS SET TO LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12601390 ↗
• MalfunctionSep 27, 2021Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS THE IMPACTOR THAT WAS WORN AND NOT MAKING ITS FUNCTION AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532729 ↗
• MalfunctionSep 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED THAT THE TIP OF THE CARDAN HEX HEAD BECOME STUCK IN THE SCREW AND WE WERE UNABLE TO DISENGAGE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12454201 ↗
• MalfunctionJul 30, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ALL INSTRUMENTS WERE DISCOVERED AS DAMAGED DURING THE CASE DUE TO GENERAL WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252407 ↗
• MalfunctionJun 18, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIPS OF SCREWDRIVERS ARE ROUNDED AND WONT FIT IN SCREWS CORRECTLY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12024771 ↗
• MalfunctionFeb 18, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ITEMS ATTACHMENT TO THE END ARE NOT STAYING KEEP POPPING OFF FROM THE END BECAUSE IT IS WORN OUT AND NEED TO REPLACE. DID NOT CAUSE ANY DELAY OR HARM JUST NEEDED TO REPLACE FOR A BETTER HOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345098 ↗
• MalfunctionJun 22, 2020Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE FLEXIBLE HEX DRIVER WAS TOO WORN DOWN TO PROPERLY SCREW IN THE HOLE ELIMINATOR. NO FURTHER INFORMATION. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10181430 ↗
• MalfunctionJun 8, 2020Break; Break

  IT WAS REPORTED THAT THE CARDAN SCREW DRIVER TIP BROKE OFF. ALL PIECES RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10129006 ↗
• MalfunctionJun 1, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE RIGID STRAIGHT SCREWDRIVER STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106577 ↗
• MalfunctionJun 25, 2019Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn

  FOLLOWING INSTRUMENTS FOUND TO BE DAMAGED, CASE WAS WITH MR (B)(6) AT THE (B)(6) HOSPITAL. NO ADVERSE EFFECT TO PATIENTS, NO DELAYS TO SURGERY. FEMORAL EXTRACTOR - WILL NOT ENGAGE WITH IMPLANT PROPERLY- THREAD IS DAMAGED. RIGID SCREW DRIVER- TIP IS WORN AND WILL NOT ENGAGE WITH SCREW. FLEX SCREWDRIVER. TIP WORN WILL NOT ENGAGE WITH SCREW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8730449 ↗
• MalfunctionFeb 22, 2019Naturally Worn; Naturally Worn

  WORN OUT FLEXIBLE DRIVER THAT REQUIRES REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8361250 ↗
• MalfunctionJan 3, 2019Material Deformation; Material Deformation

  THE DRILL BIT ON THE FLEXIBLE ONE PIECE DRILL BIT SNAPPED DURING USE, THE SCREW DRIVERS WERE ALL REPORTED BY THE SURGEON TO BE DAMAGED. THE RATCHET HANDLE WAS JAMMED AND UNABLE TO BE USED AS DESIGNED.

  Patient problems: Not Applicable

  MAUDE report 8212462 ↗
• MalfunctionOct 1, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SCREWDRIVERS STRIPPED OUT DURING SURGERY, WON'T TURN SCREWS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7923849 ↗
• MalfunctionSep 26, 2018Break; Break

  REPORTED BROKEN INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7910599 ↗
• MalfunctionJun 18, 2018Bent; Bent

  IT WAS REPORTED THAT THE RATCHET STOPPED RATCHETING, AND BENT THE SPRING DRIVER. SURGICAL DELAY OF 1 MINUTE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7609888 ↗