P.F.C. 86-9199Recalls & reported problems
Depuy (Ireland) · P.F.C. DRILL 5/16 in · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295218203), received between Nov 19, 2021 and Sep 6, 2022 — classified as 4 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
- Failure to Cut4
- Naturally Worn3
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2022Break; Failure to Cut; Break; Failure to Cut
IT WAS REPORTED THAT THE ITEM IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15362069 ↗MalfunctionNov 19, 2021Break; Failure to Cut; Naturally Worn; Break; Failure to Cut; Naturally Worn
IT WAS REPORTED THAT THE DRILLS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12843926 ↗MalfunctionNov 19, 2021Break; Failure to Cut; Naturally Worn; Break; Failure to Cut; Naturally Worn
IT WAS REPORTED THAT THE DRILLS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12843919 ↗MalfunctionNov 19, 2021Break; Failure to Cut; Naturally Worn; Break; Failure to Cut; Naturally Worn
IT WAS REPORTED THAT THE DRILLS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12843909 ↗
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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