N/A 96-6877Recalls & reported problems
Depuy (Ireland) · UNIVERSAL PRESS-FIT STEM TRIAL 16mm x 75mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295496434), received between Jul 12, 2021 and Oct 16, 2024 — classified as 5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2024Break; Break
THE THREADED END HAS BROKEN OFF AND DAMAGED INTO THE STEM TRIAL.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20462315 ↗MalfunctionJul 24, 2023Break; Break
IT WAS REPORTED THAT THE PRONGS ON THE STEM TRIAL BROKE OFF AFTER REMOVAL OF THE TRIAL. ALL PIECES WERE RETRIEVED AND CONTAINED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17378788 ↗MalfunctionNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE TIP OF STEM EXTRACTOR WAS BROKEN WHILE TRYING TO REMOVE THE 16 MM STEM TRIAL. BOTH STEM AND TRIAL ARE BEING RETURNED AND ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12881867 ↗MalfunctionJul 12, 2021Break; Break
IT WAS REPORTED THAT WHEN RESETTING INSTRUMENTS THE PEGS ON BOTH 75X16 STEM TRIALS WERE BROKEN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12155664 ↗MalfunctionJul 12, 2021Break; Break
IT WAS REPORTED THAT WHEN RESETTING INSTRUMENTS THE PEGS ON BOTH 75X16 STEM TRIALS WERE BROKEN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12155660 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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