QUICKSET 2274-53-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10603295109280), received between Nov 21, 2017 and Jun 10, 2025 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (15 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED THAT THE CARDAN DRIVER BROKE FOLLOWED BY KNUCKLE DRIVER BREAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177062 ↗
• MalfunctionDec 31, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE, THE RIGID QUICK COUPLE DID NOT HOLD THE DRILL BITS PROPERLY. THE DRILL BIT WOULD ATTACH TO THE QUICK COUPLE BUT THEN DISCONNECTED WHEN DRILLED IN THE BONE. SO A SECOND SET WAS OPENED. THE QUICK COUPLE IN THE 2ND SET ALSO DID NOT HOLD THE DRILL BITS PROPERLY, SO A 3RD SET WAS OPENED AND THE QUICK COUPLE IN THAT SET WORKED PROPERLY. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047750 ↗
• MalfunctionDec 31, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE, THE RIGID QUICK COUPLE DID NOT HOLD THE DRILL BITS PROPERLY. THE DRILL BIT WOULD ATTACH TO THE QUICK COUPLE BUT THEN DISCONNECTED WHEN DRILLED IN THE BONE. SO A SECOND SET WAS OPENED. THE QUICK COUPLE IN THE 2ND SET ALSO DID NOT HOLD THE DRILL BITS PROPERLY, SO A 3RD SET WAS OPENED AND THE QUICK COUPLE IN THAT SET WORKED PROPERLY. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047748 ↗
• MalfunctionJun 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PINNACLE SCREW GETS STUCK ON THE UNIVERSAL DRIVER SHAFT. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19565967 ↗
• MalfunctionApr 10, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING THE COURSE OF NORMAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080262 ↗
• MalfunctionApr 10, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING THE COURSE OF NORMAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080207 ↗
• MalfunctionJan 8, 2024Break; Material Deformation; Break; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED: DID THE EVENT OCCUR DURING THE SURGERY? YES. WAS THERE A SURGICAL DELAY? NO. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464622 ↗
• MalfunctionDec 5, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  THE DRILL FLEXIBLE HANDLE IS DAMAGED; IT DOES NOT HOLD THE DRILL. WHEN USING WITH THE ENGINE, THE DRILL BIT IS RELEASED FROM THE FLEXIBLE DRILL BIT HOLDER. THERE WAS A 5 MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 18265547 ↗
• MalfunctionNov 9, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT 2 HANDLES ARE DEFECTIVE. THEY DON¿T LOCK THE HANDLE BITS PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099964 ↗
• MalfunctionOct 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FLEXIBLE PINNACLE DRILL SHAFT WAS WORN AND WON¿T HOLD DRILL BIT. TRIED MULTIPLE DRILL BITS. TRIED USING RIGID ONE INSTEAD BUT DRILL BIT SNAPPED IN SHAFT; BROKEN PART OF THE DRILL BIT STUCK IN SHAFT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950396 ↗
• MalfunctionJun 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RIGID DRILL SHAFT IS NOT HOLDING WHEN IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17063809 ↗
• MalfunctionApr 25, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806113 ↗
• MalfunctionApr 25, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806109 ↗
• MalfunctionApr 25, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806099 ↗
• MalfunctionApr 25, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806096 ↗
• MalfunctionApr 25, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806082 ↗
• MalfunctionApr 25, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806070 ↗
• MalfunctionApr 25, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806058 ↗
• MalfunctionApr 25, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806057 ↗
• MalfunctionApr 25, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806053 ↗
• MalfunctionApr 25, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806046 ↗
• MalfunctionApr 25, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806037 ↗
• MalfunctionApr 25, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806024 ↗
• MalfunctionApr 21, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16787101 ↗
• MalfunctionApr 21, 2023Naturally Worn; Naturally Worn

  INSTRUMENTS ARE WORN. NO REPORTED DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16787086 ↗