Skip to content

NA 6900727Recalls & reported problems

Smith & Nephew, Inc. · MTO REFURB SWICHING STICK 3.6 REF 4308 · 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 00885554006438), received between Mar 31, 2021 and Mar 31, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (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

  • Sharp Edges2

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 31, 2021Sharp Edges; Sharp Edges

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE MTO REFURB SWITCHING STICK 3.6 REF 4308 WAS TOO SKINNY AND IT WAS TOO FLEXIBLE, IT WAS QUITE FLIMSY AND SHARP. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY NOR PATIENT INJURY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11594799 ↗
  • MalfunctionMar 31, 2021Sharp Edges; Sharp Edges

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE MTO REFURB SWITCHING STICK 3.6 REF 4308 WAS TOO SKINNY AND IT WAS TOO FLEXIBLE, IT WAS QUITE FLIMSY AND SHARP. THIS HAPPENED WITH A TOTAL OF 2 DEVICES. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY NOR PATIENT INJURY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11594768 ↗

Other ACCESSORIES,ARTHROSCOPIC devices

All ACCESSORIES,ARTHROSCOPIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.