P.F.C. 86-4348Recalls & reported problems
Depuy (Ireland) · P.F.C. BONE FILE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295216520), received between Nov 6, 2018 and Sep 30, 2020 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (7 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
- Dull, Blunt7
- Naturally Worn1
Patient problems
- No Consequences Or Impact To Patient8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2020Dull, Blunt; Dull, Blunt
HOSPITAL CONSIGNED UNIVERSAL BONE FILES HAS REACHED ITS POINT OF DULLNESS AND REQUIRES REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10606629 ↗MalfunctionSep 30, 2020Dull, Blunt; Dull, Blunt
HOSPITAL CONSIGNED UNIVERSAL BONE FILES HAS REACHED ITS POINT OF DULLNESS AND REQUIRES REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10606625 ↗MalfunctionSep 30, 2020Dull, Blunt; Dull, Blunt
HOSPITAL CONSIGNED UNIVERSAL BONE FILES HAS REACHED ITS POINT OF DULLNESS AND REQUIRES REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10606624 ↗MalfunctionSep 30, 2020Dull, Blunt; Dull, Blunt
HOSPITAL CONSIGNED UNIVERSAL BONE FILES HAS REACHED ITS POINT OF DULLNESS AND REQUIRES REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10606622 ↗MalfunctionSep 30, 2020Dull, Blunt; Dull, Blunt
HOSPITAL CONSIGNED UNIVERSAL BONE FILES HAS REACHED ITS POINT OF DULLNESS AND REQUIRES REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10606621 ↗MalfunctionSep 30, 2020Dull, Blunt; Dull, Blunt
HOSPITAL CONSIGNED UNIVERSAL BONE FILES HAS REACHED ITS POINT OF DULLNESS AND REQUIRES REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10606620 ↗MalfunctionOct 7, 2019Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE BONE FILE WAS WORN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9162568 ↗MalfunctionNov 6, 2018Dull, Blunt; Dull, Blunt
BONE FILE REPORTED TO BE BLUNT BY SURGEON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8041292 ↗
Other FILE devices
- SIGMA 2024-85-004Depuy (Ireland) · FILE1 report
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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