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QUICKSET 2274-58-000Recalls & reported problems

Depuy (Ireland) · QUICKSET 3.8mm DIA DRILL BIT 55mm · Class 1

Quick summary

This DePuy Quickset drill bit is a Class 1 surgical drill bit. Reports mostly describe drill bits breaking, wearing down, or failing to cut before or during surgery, sometimes generating fragments that are removed. There are 80 adverse event reports naming its identifier: 80 malfunctions, no deaths and no injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
79
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10603295109334), received between Aug 2, 2017 and Jun 25, 2026 — classified as 79 malfunctions.

The most frequently reported specific device problem is “Break” (40 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 3 reportsJun 2025: 2 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break40
  • Naturally Worn24
  • Failure to Cut17
  • Material Deformation5
  • Dull, Blunt1
  • Entrapment of Device1
  • Scratched Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions61
  • No Code Available5
  • No Patient Involvement4
  • Not Applicable4
  • Insufficient Information3
  • Foreign Body In Patient2
  • No Information1

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 25, 2026Break

    IT WAS REPORTED THAT PRIOR TO SURGERY IT WAS OBSERVED THAT THE DRILL BITS WERE BROKEN. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25621123 ↗
  • MalfunctionApr 30, 2026Break; Scratched Material

    IT WAS REPORTED THAT THE STERILE SERVICES DEPARTMENT INDICATED THAT THE DRILL BITS HAD SNAPPED AFTER STERILIZATION AND WERE HEAVILY SCRATCHED OR DAMAGED. ALL AFFECTED ITEMS WERE DISPOSED OF ONSITE, AND THERE WAS NO IMPACT ON ANY PATIENT, WITH ALL BROKEN PIECES ACCOUNTED FOR AND NONE LEFT INSIDE A PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25048747 ↗
  • MalfunctionMar 13, 2026Break

    IT WAS REPORTED THAT CENTRAL STERILE SERVICES DEPARTMENT (CSSD) INFORMED THAT THE INSTRUMENT ON THE HIP SET IS DAMAGED/BROKEN. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24591503 ↗
  • 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 23315838 ↗
  • MalfunctionJul 23, 2025Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE DRILL BIT WAS DAMAGED INTRAOPERATIVELY. THERE WAS 1 MINUTE OF SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22580277 ↗
  • 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 22532295 ↗
  • MalfunctionJun 9, 2025Break; Break

    IT WAS REPORTED THAT THE DRILL BITS SNAPPED OVER TIME WHEN DRILLING BONE.

    Patient problems: Insufficient Information

    MAUDE report 22167025 ↗
  • MalfunctionJun 9, 2025Break; Break

    IT WAS REPORTED THAT THE DRILL BITS SNAPPED OVER TIME WHEN DRILLING BONE.

    Patient problems: Insufficient Information

    MAUDE report 22167008 ↗
  • MalfunctionMay 15, 2025Break; Break

    IT WAS REPORTED MULTIPLE DRILL BITS HAVE BROKEN OFF OVER MANY MONTHS. NO SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22027999 ↗
  • MalfunctionMay 15, 2025Break; Break

    IT WAS REPORTED MULTIPLE DRILL BITS HAVE BROKEN OFF OVER MANY MONTHS. NO SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22027823 ↗
  • MalfunctionMay 15, 2025Break; Break

    IT WAS REPORTED MULTIPLE DRILL BITS HAVE BROKEN OFF OVER MANY MONTHS. NO SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22027409 ↗
  • MalfunctionNov 6, 2024Break; Break

    IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE DRILL BIT BROKE INTO TWO PIECE WHILE IN USE. THE PIECE THAT BROKE OFF WAS IMMEDIATELY RETRIEVED FROM THE PATIENT AND THE CASE CONTINUED WITHOUT FURTHER INCIDENT. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20625030 ↗
  • MalfunctionOct 20, 2023Break; Break

    IT WAS REPORTED THAT THE DEVICE BROKE WHILE USE. 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 --> , 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)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE,(B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). 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 17977230 ↗
  • MalfunctionOct 20, 2023Break; Break

    IT WAS REPORTED THAT THE DEVICE BROKE WHILE IN USE. 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 , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, AND IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17977078 ↗
  • 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 16806262 ↗
  • 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 16806126 ↗
  • 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 16786863 ↗
  • 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 16786862 ↗
  • 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 16786851 ↗
  • 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 16786816 ↗
  • 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 16786585 ↗
  • 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 16786570 ↗
  • 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 16786559 ↗
  • 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 16786529 ↗
  • 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 16786491 ↗

Other BIT, DRILL devices

All BIT, DRILL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.