DJO SURGICAL 801-01-020Recalls & reported problems
Encore Medical, L.P. · DRILL BIT, 1/8" · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912042710), received between Jun 30, 2017 and Apr 19, 2021 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
Device problems
- Break4
- Component Falling1
- Device Operates Differently Than Expected1
- Difficult to Remove1
- Improper or Incorrect Procedure or Method1
Patient problems
- Device Embedded In Tissue or Plaque2
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 19, 2021Break
INSTRUMENT FAILURE - DUE TO ITEM BROKE WHILE USING GEN 1 GLENOID DRILL GUIDE. DRILL BROKE AT BASE OF CUTTING FLUTES ~22MM FROM DRILL TOP. NO PIECES LEFT IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11691043 ↗InjuryDec 4, 2017Break; Component Falling
INSTRUMENT FAILURE - THE SURGEON PUT THE 3.2MM DRILL IN THE DRILL GUIDE AND STARTED TO DRILL WHEN THE BASE OF THE DRILL BROKE AND FELL INSIDE PATIENT. THERE WAS NO ABNORMAL FORCE USED WHILE DRILLING BY THE SURGEON. NOTHING OUT OF THE ORDINARY WAS NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7080886 ↗InjuryNov 30, 2017Break
COMPLAINT: IN THE MIDST OF A FIXATION OF THE TRIAL COMPONENT BY TIBIAL BONE PIN, AFTER DRILLING WITH 3.2MM DRILL BIT, THE DRILL TIP WAS BROKEN AND THE FRAGMENT REMAINED IN THE PATIENT MEDULLARY CAVITY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7072777 ↗MalfunctionJun 30, 2017Break; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected
INSTRUMENT FAILURE - THE SURGEON WAS DRILLING AT AN INCORRECT ANGLE AND THE DRILL BIT SNAPPED. WHEN TRYING TO RETRIEVE IT THE SURGEON JUST MANAGED TO PUSH IT IN FARTHER. LEFT IN PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6682063 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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