NA 9400-80-001Recalls & reported problems
Depuy (Ireland) · PROXIMA CANAL FINDER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295223597), received between Jan 7, 2022 and Dec 18, 2025 — classified as 6 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
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2025Break; Break
IT WAS REPORTED THAT BROKEN T HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846305 ↗MalfunctionDec 18, 2025Break; Break
IT WAS REPORTED THAT BROKEN T HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846304 ↗MalfunctionJul 29, 2025Break; Break
IT WAS REPORTED THAT CUP IMPACTOR HANDLE SHAFT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22649249 ↗MalfunctionJul 28, 2025Break; Break
IT WAS REPORTED THAT THE TIP OF CANAL FINDER IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22629281 ↗MalfunctionJan 27, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT T-HANDLE CANAL FINDER WAS BENT. THIS LIKELY HAPPENED WHEN CLEANING/STERILIZING IN SPD AND HAD NO RELEVANCE OR IMPACT ON THE CASE AND PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16251663 ↗MalfunctionJan 7, 2022Break; Break
CANAL FINDER TIP HAS A LITTLE METAL SHAVING ON THE TIP AND IS FAIRLY SHARP. THE OFFSET REAMER HAS THE PLASTIC CASING ON THE INSIDE SCRATCHED AND SPD CLAIMS THE INSTRUMENT CANNOT BE STERILIZED. THERE WAS NO SURGICAL DELAY. DOE: (B)(6) 2021.
Patient problems: Insufficient Information
MAUDE report 13196787 ↗
Other PROBE devices
- EXPEDIUM 279702030Depuy Spine, LLC · PROBE53 reports
- Sklar 96-2361Sklar Corporation · PROBE1 recall0 reports
- Sklar Instruments 94-5923Sklar Corporation · PROBE1 recall0 reports
- MOSS 275010140Depuy Spine, LLC · PROBE28 reports
- EXPEDIUM 279702040Depuy Spine, LLC · PROBE21 reports
- MULTILOC 03.019.029Synthes GmbH · PROBE15 reports
- MOSS 275010160Depuy Spine, LLC · PROBE11 reports
- EXPEDIUM 279702010Depuy Spine, LLC · PROBE9 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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