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QUICKSET 2274-25-500Recalls & reported problems

Depuy Orthopaedics, Inc. · QUICKSET 3.8mm 1 PC FLEX DRILL BIT 25mm LGT · Class 1

Quick summary

This DePuy QuickSet flexible drill bit is used in orthopaedic surgery. Most reports describe the bit breaking during use, and others mention it bending, twisting or failing to cut, with some reports noting that broken pieces were retrieved. The records include 1,999 reports, 9 injuries and no deaths, and 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
1,985
Deaths reported
0
Injuries reported
9
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1,985 adverse event reports that list this exact device (DI 10603295109129), received between Dec 17, 2015 and Sep 29, 2026 — classified as 9 injuries, 1,976 malfunctions.

The most frequently reported specific device problem is “Break” (1,322 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: 24 reportsDec 2023: 12 reportsJan 2024: 6 reportsFeb 2024: 18 reportsMar 2024: 13 reportsApr 2024: 15 reportsMay 2024: 15 reportsJun 2024: 19 reportsJul 2024: 11 reportsAug 2024: 15 reportsSep 2024: 11 reportsOct 2024: 21 reportsNov 2024: 19 reportsDec 2024: 3 reportsJan 2025: 23 reportsFeb 2025: 10 reportsMar 2025: 15 reportsApr 2025: 7 reportsMay 2025: 23 reportsJun 2025: 11 reportsJul 2025: 21 reportsAug 2025: 20 reportsSep 2025: 12 reportsOct 2025: 17 reportsNov 2025: 18 reportsDec 2025: 32 reportsJan 2026: 24 reportsFeb 2026: 18 reportsMar 2026: 23 reportsApr 2026: 26 reportsMay 2026: 37 reportsJun 2026: 14 reportsJul 2026: 7 reportsAug 2026: 8 reportsSep 2026: 7 reportsOct 2026: 0 reports20242025202637
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break1,322
  • Material Deformation300
  • Material Twisted/Bent157
  • Failure to Cut110
  • Dull, Blunt50
  • Entrapment of Device50
  • Bent43
  • Corroded31

Patient problems

  • No Clinical Signs, Symptoms or Conditions1,092
  • No Consequences Or Impact To Patient621
  • Insufficient Information160
  • No Information114
  • No Code Available42
  • Not Applicable30
  • Foreign Body In Patient19
  • No Known Impact Or Consequence To Patient5

Recent adverse event reports

The 25 most recent of 1,985 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 29, 2026Material Deformation

    It was reported that drill bit was bent. Calcar reamer was dull. No adverse affects to the patient. No additional information was available.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50932934 ↗
  • MalfunctionSep 25, 2026Material Deformation

    It was reported that the drill bit tip was bent. No adverse affects to the patient. No additional information is available.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50898713 ↗
  • MalfunctionSep 24, 2026Break

    It was reported that drill bit tip broke during case.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50886242 ↗
  • MalfunctionSep 22, 2026No Apparent Adverse Event

    It was reported that on an unknown date, the products had an unknown allegation.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50856911 ↗
  • MalfunctionSep 21, 2026Break

    It was reported that during a Total Hip Replacement, the drill bit broke as doctor was drilling screw holes. There was no delays. Nothing left in patient.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50845682 ↗
  • MalfunctionSep 21, 2026Material Deformation

    It was reported that during a surgical procedure, the 25mm drill bit bent while drilling for acetabular screw. There was no negative outcome and no surgical delay. All available information has been provided.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50841514 ↗
  • MalfunctionSep 18, 2026Break

    It was reported that during a total hip replacement surgery a drill bit broke while drilling. It broke into two pieces. The broken piece was found and removed from the patient. All available information has been disclosed.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50819256 ↗
  • MalfunctionAug 24, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50419266 ↗
  • MalfunctionAug 14, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50261375 ↗
  • MalfunctionAug 11, 2026Material Deformation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50214953 ↗
  • MalfunctionAug 11, 2026Material Deformation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50214600 ↗
  • MalfunctionAug 11, 2026Material Deformation

    It was reported that the 25mm drill bent during case and needs replaced. No adverse consequences no time added.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50213496 ↗
  • MalfunctionAug 7, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50174998 ↗
  • MalfunctionAug 7, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50174991 ↗
  • MalfunctionAug 7, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50174335 ↗
  • MalfunctionJul 15, 2026Material Deformation

    IT WAS REPORTED THE TIP OF THE ACTIS THREADED INSERTER WAS DEFORMED. THIS WAS OBSERVED DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25826471 ↗
  • MalfunctionJul 10, 2026Material Deformation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25777848 ↗
  • MalfunctionJul 9, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25764888 ↗
  • MalfunctionJul 1, 2026Material Deformation

    IT WAS REPORTED THAT X4 QUICKSET FLEXIBLE BITS 25 MM ARE BENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25681948 ↗
  • MalfunctionJul 1, 2026Material Deformation

    IT WAS REPORTED THAT X4 QUICKSET FLEXIBLE BITS 25 MM ARE BENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25681945 ↗
  • MalfunctionJul 1, 2026Material Deformation

    IT WAS REPORTED THAT X4 QUICKSET FLEXIBLE BITS 25 MM ARE BENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25681944 ↗
  • MalfunctionJul 1, 2026Crack

    IT WAS REPORTED THAT THE DEVICE CRACKED WHILE DRILLING FOR SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25679344 ↗
  • MalfunctionJun 26, 2026Material Deformation

    IT WAS REPORTED THAT THE ISSUE DID NOT OCCUR DURING SURGERY; SPD NOTIFIED THAT TWO 25MM PINNACLE DRILL BITS WERE DISCARDED DUE TO BEING BENT AT THE TIP, WITH NOTHING FURTHER TO REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25638977 ↗
  • MalfunctionJun 24, 2026Material Deformation

    IT WAS REPORTED THAT 25MM DRILL WAS BENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25608798 ↗
  • MalfunctionJun 19, 2026Break

    IT WAS REPORTED THAT THE DRILL BIT BROKE INTO TWO PIECES DURING USE. THE BROKEN TIP WAS RETRIEVED AND NOTHING REMAINED IN THE PATIENT. THE PROCEDURE WAS FINISHED WITH ANOTHER DRILL BIT. THERE WAS NO DELAY OR EXTENDED SURGICAL TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25563150 ↗

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.