P.F.C. 86-4192Recalls & reported problems
Depuy Orthopaedics, Inc. · P.F.C. DRILL BIT AND STEINMAN PIN PACKET (1 UNIT) .125in DIA 5in LGTH · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295216476), received between Aug 10, 2017 and Mar 25, 2025 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
Most reported problems
Device problems
- Break5
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Consequences Or Impact To Patient2
- No Information2
- Insufficient Information1
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT BEFORE OPENING THE PIN PACK, THE NURSE OBSERVED PLASTIC SEAL WAS COMPROMISED AND QUESTIONED STERILITY.
Patient problems: Insufficient Information
MAUDE report 21686199 ↗MalfunctionAug 24, 2018Break; Break
IT WAS REPORTED DURING A TOTAL KNEE PROCEDURE SURGEON USED THE DRILL FROM THE DRILL AND PIN PACK TO MAKE PILOT HOLES AND THE DRILL BECAME LODGED IN THE 7 DEGREE LCS TIBIAL CUTTING BLOCK AND BROKE OFF IN THE CUTTING BLOCK. THE SECOND DRILL FROM THE PIN PACK WAS USED DRILL THE SECOND PILOT HOLE AND IT ALSO BECAME LODGED AND BROKE OFF IN THE CUTTING BLOCK. SURGEON BELIEVES THE DIAMETER OF THE DRILL BIT WAS TOO LARGE FOR THE CUTTING BLOCK. HE STATED THAT THEY SEEMED TIGHTER THAN NORMAL. THE CUTTING BLOCK WITH THE 2 DRILL BITS WILL BE RETURNED FOR INSPECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7812615 ↗InjuryApr 5, 2018Break; Break
IT WAS REPORTED THAT THE DRILL BIT SNAPPED OFF IN CUTTING GUIDE. THERE WAS A 15 MINUTES SURGICAL DELAY. ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Code Available; Not Applicable
MAUDE report 7399115 ↗MalfunctionFeb 13, 2018Break; Break
IT WAS REPORTED DURING A TOTAL KNEE PROCEDURE SURGEON USED THE DRILL FROM THE DRILL AND PIN PACK TO MAKE PILOT HOLES AND THE DRILL BECAME LODGED IN THE 7 DEGREE LCS TIBIAL CUTTING BLOCK AND BROKE OFF IN THE CUTTING BLOCK. THE SECOND DRILL FROM THE PIN PACK WAS USED DRILL THE SECOND PILOT HOLE AND IT ALSO BECAME LODGED AND BROKE OFF IN THE CUTTING BLOCK. SURGEON BELIEVES THE DIAMETER OF THE DRILL BIT WAS TOO LARGE FOR THE CUTTING BLOCK. HE STATED THAT THEY SEEMED TIGHTER THAN NORMAL. THE CUTTING BLOCK WITH THE 2 DRILL BITS WILL BE RETURNED FOR INSPECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7266048 ↗MalfunctionSep 6, 2017Break; Break
IT WAS REPORTED THAT THE DRILL BIT BECAME LOCKED AND BROKE OFF IN THE TIBIAL CUTTING BLOCK.
Patient problems: No Information
MAUDE report 6846815 ↗MalfunctionAug 10, 2017Break; Break
IT WAS REPORTED THAT THE DRILL BIT BROKE INSIDE THE ANATOMIC RESECTION GUIDE. IT WAS BROKE DURING SURGERY.
Patient problems: No Information
MAUDE report 6784225 ↗
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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