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LCS 2366-86-000Recalls & reported problems

Depuy (Ireland) · LCS DRILL BIT 3.2mm x 25mm · Class 1

All models of LCS (5)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
16
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295120209), received between Mar 5, 2020 and May 7, 2026 — classified as 16 malfunctions.

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

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 2 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 2 reportsMar 2025: 0 reportsApr 2025: 3 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 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

  • Break15
  • Entrapment of Device1
  • Failure to Cut1

Patient problems

  • No Clinical Signs, Symptoms or Conditions8
  • Insufficient Information6
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 7, 2026Break

    IT WAS REPORTED THAT DRILL BIT SNAPPED WHILE DRILLING IN THE PLASTIC TO TAKE THE LINER OUT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25115920 ↗
  • MalfunctionJul 21, 2025Break; Break

    IT WAS REPORTED THAT THERE WAS A BROKEN ANGLED DRILL AND DRILL BIT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22555999 ↗
  • MalfunctionApr 2, 2025Break; Break

    IT WAS REPORTED THAT THE DRILL BITS BROKE, NO PATIENT WAS AFFECTED OR HARMED. THE EVENT DID NOT HAPPEN IN SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21755205 ↗
  • MalfunctionApr 2, 2025Break; Break

    IT WAS REPORTED THAT THE DRILL BITS BROKE, NO PATIENT WAS AFFECTED OR HARMED. THE EVENT DID NOT HAPPEN IN SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21755065 ↗
  • MalfunctionApr 2, 2025Break; Break

    IT WAS REPORTED THAT THE DRILL BITS BROKE, NO PATIENT WAS AFFECTED OR HARMED. THE EVENT DID NOT HAPPEN IN SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21755006 ↗
  • MalfunctionFeb 24, 2025Break; Break

    IT WAS REPORTED THAT THE 25MM DRILL BITS SNAPPED WHILE DRILLING FOR SCREWS. SURGICAL DELAY WAS UNKNOWN.

    Patient problems: Insufficient Information

    MAUDE report 21446423 ↗
  • MalfunctionFeb 24, 2025Break; Break

    IT WAS REPORTED THAT THE 25MM DRILL BITS SNAPPED WHILE DRILLING FOR SCREWS. SURGICAL DELAY WAS UNKNOWN.

    Patient problems: Insufficient Information

    MAUDE report 21446348 ↗
  • MalfunctionJun 5, 2024Break; Break

    IT WAS REPORTED THAT THE 25MM DRILL BIT WAS SNAPPED DURING USE. BIT WAS DISCARDED. ALL PIECES WERE REMOVED FROM THE PATIENT.

    Patient problems: Insufficient Information

    MAUDE report 19467548 ↗
  • MalfunctionMay 1, 2024Break; Break

    IT WAS REPORTED THAT THE DRILL BITS SNAPPED WHEN DRILLING INTO LINER.

    Patient problems: Insufficient Information

    MAUDE report 19225671 ↗
  • MalfunctionMay 1, 2024Break; Break

    IT WAS REPORTED THAT THE DRILL BITS SNAPPED WHEN DRILLING INTO LINER.

    Patient problems: Insufficient Information

    MAUDE report 19225563 ↗
  • MalfunctionMar 14, 2024Break; Break

    IT WAS REPORTED THAT THE 25MM DRILL BIT SNAPPED WHILE DRILLING FOR SCREWS. IT WAS UNKNOWN ABOUT SURGICAL DELAY.

    Patient problems: Insufficient Information

    MAUDE report 18901803 ↗
  • MalfunctionMay 26, 2023Failure to Cut; Failure to Cut

    IT WAS REPORTED THAT THE DRILL BIT WAS DULL .

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17010928 ↗
  • MalfunctionJun 3, 2022Break; Break

    IT WAS REPORTED THAT THE DRILL BIT IS BROKEN. NO ADVERSE EFFECTS TO THE PATIENT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14597000 ↗
  • MalfunctionApr 26, 2021Break; Entrapment of Device; Break; Entrapment of Device

    VOLUNTARY REPORT RECEIVED UNDER MW IMPORTER REPORT # 4100120000-2021-8010. IT WAS REPORTED THAT THE DEPUY SYNTHES ACETABULAR SCREW DRILL BIT BROKE AND WAS RETAINED INSIDE THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11728593 ↗
  • MalfunctionMar 27, 2020Break; Break

    MAUDE REPORT: RECEIVE: IT WAS REPORTED THAT THE DRILL BIT BROKE INTO TWO PIECES, BOTH PIECES WERE RECOVERED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9888659 ↗
  • MalfunctionMar 5, 2020Break

    DRILL BIT BROKE INTO TWO PIECES, BOTH PIECES WERE RECOVERED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9792308 ↗

Other BIT, DRILL devices

All BIT, DRILL devices →

Sources and updates

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