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DYONICS POWER 7205786Recalls & reported problems

Smith & Nephew, Inc. · DYONICS POWER SAGITTAL SAW · Class 1

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 03596010410719), received between Aug 17, 2017 and May 17, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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

  • Device Operates Differently Than Expected2
  • Overheating of Device2

Patient problems

  • No Known Impact Or Consequence To Patient4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 17, 2019Overheating of Device

    IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, THE SAGGITAL SAW OVERHEATED; THE HANDLE WAS UNABLE TO BE GRABBED. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY. NEITHER THE PATIENT NOR THE USER SUFFER ANY INJURY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8620401 ↗
  • MalfunctionDec 6, 2017Device Operates Differently Than Expected

    IT WAS REPORTED THAT DURING THE ROUTINE INSPECTION THE DEVICE DID NOT MOVE. NO PATIENT WAS INVOLVED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7088995 ↗
  • MalfunctionNov 30, 2017Overheating of Device

    IT WAS REPORTED THAT DYONICS POWER SAGITTAL SAW WAS NOT OPERATING AND THEN THE HAND PIECE STARTED TO OVERHEAT. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7072577 ↗
  • MalfunctionAug 17, 2017Device Operates Differently Than Expected

    IT WAS REPORTED THE DEVICE DOES NOT WORK AT ALL TIMES WHEN THE HANDLE IS PRESSED. SOMETIMES THOUGH, IT WILL STAY PERMANENTLY ON EVEN WHEN SWITCHED TO SAFE MODE. NO INJURIES OR COMPLICATIONS WERE REPORTED AS A RESULT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6802659 ↗

Other SAW, POWERED, AND ACCESSORIES devices

All SAW, POWERED, AND ACCESSORIES devices →

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