TC-PLUS / RT-PLUS 75100394Recalls & reported problems
Smith & Nephew, Inc. · TC REV/RT/RT MOD. SLAP HAMMER · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996117837), received between Mar 25, 2021 and Mar 26, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING INSPECTION PROCESS, THE TC REV/RT/RT MOD. SLAP HAMMER THREADED STUD WAS FOUND TO BE BENT. THERE WAS NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11574704 ↗MalfunctionMar 25, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING INSPECTION THE ROD ON THE SLAP HAMMER WAS NOTICED BENT AND THE HAMMER DOESN'T SLIDE. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11568219 ↗
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- NA 03.010.059Synthes GmbH · MALLET1 report
- Integra® Miltex® 19-790Integra Lifesciences Production Corporation · MALLET1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.