INTUITION 2525-45-005Recalls & reported problems
Depuy (Ireland) · INTUITION FOR HP PARTIAL PIN PACK · Class 1
All models of INTUITION (23)
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 10603295547860), received between May 6, 2025 and Sep 10, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Device-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Break; Device-Device Incompatibility
It was reported that during a procedure, the short threaded headed pin sheared off when pinning the posterior cutting block from Sigma partial instrumentation. It was unable to be removed. No delay to surgery or harm to patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715191 ↗MalfunctionDec 13, 2025Device-Device Incompatibility; Device-Device Incompatibility
SIGMA HP UNI CUTTING BLOCK LEFT. THE PIN GOT STUCK DURING SURGERY IN THE BLOCK. NO ISSUE FOR THE PATIENT. SURGERY DELAY 2-5 MIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23797647 ↗MalfunctionJun 27, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROBOTIC SIGMA PARTIAL KNEE REPLACEMENT. WHEN PINNING THE TIBIAL PREP PLATE INTO THE TIBIA, ONE OF THE SHORT TIBIAL PINS SNAPPED, LEAVING PART OF IT IN THE BONE. THIS WAS EXTRACTED WITHOUT DELAY OR HARM TO THE PATIENT AND TIBIAL PREP WAS COMPLETED USING THE SECOND PIN. SURGEON MENTIONED PATIENT HAD VERY SCLEROTIC BONE WHICH MAY HAVE BEEN A FACTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22346353 ↗MalfunctionMay 6, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UKA. DURING THE SURGERY, UNKNOWN DEFECT OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 21969471 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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