Harmony 74016464Recalls & reported problems
Smith & Nephew, Inc. · MIS 3.2MM X 30MM RIMMED PIN STERILE · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556691977), received between Oct 6, 2023 and Oct 6, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT DURING TKA SURGERY, WHILE ATTEMPTING TO PIN DOWN THE TRIAL TIBIA BASEPLATE THE MIS 3.2MM X 30MM RIMMED PIN STERILE WAS DROPPED INTO THE INTRAMEDULLARY HOLE THAT WAS PREVIOUSLY DRILLED BY THE SURGEON. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE RIMMED SPEED PIN FROM THE PATIENTS TIBIA, BUT THE SURGEON DECIDED TO LEAVE THE PIECE INSIDE OF THE PATIENT AND PROCEED TO IMPLANT THE FINAL PRESSFIT TIBIA PLATE. THE PROCEDURE WAS COMPLETED AFTER A NON SIGNIFICANT DELAY USING A S+N BACK UP DEVICE.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 17890927 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.