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DYONICS POWER 7209391Recalls & reported problems

Smith & Nephew, Inc. · DYONICS PWR HIGH SPEED DRILL · Class 1

Adverse event reports
4
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010466167), received between Jan 30, 2018 and Jul 12, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 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

  • Overheating of Device3
  • Failure to Power Up1
  • Protective Measures Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJul 12, 2021Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT DURING AN IP JOINT FUSION THE DYONICS PWR HIGH SPEED DRILL DID NOT HAVE ANY POWER. HAND PIECE CONTROL ERROR MESSAGE WAS DISPLAYED IN THE SCREEN. INSTRUMENTS INSIDE PATIENT. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. BACKUP DEVICE AVAILABLE. NO PATIENT COMPLICATIONS REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT OVERHEATED WHICH MAKES IT A REPORTABLE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12155148 ↗
  • MalfunctionJul 12, 2021Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT DURING AN IP JOINT FUSION THE DYONICS PWR HIGH SPEED DRILL DID NOT HAVE ANY POWER. HAND PIECE CONTROL ERROR MESSAGE WAS DISPLAYED IN THE SCREEN. INSTRUMENTS INSIDE PATIENT. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. BACKUP DEVICE AVAILABLE. NO PATIENT COMPLICATIONS REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT OVERHEATED WHICH MAKES IT A REPORTABLE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12155084 ↗
  • InjuryApr 25, 2021Failure to Power Up; Protective Measures Problem; Failure to Power Up; Protective Measures Problem

    IT WAS REPORTED THAT DURING AN IP JOINT FUSION THE DYONICS PWR HIGH SPEED DRILL DID NOT HAVE ANY POWER. THIS EVENT HAPPENED WITH A DYONICS PWR HIGH SPEED DRILL. HAND PIECE CONTROL ERROR MESSAGE WAS DISPLAYED IN THE SCREEN. INSTRUMENTS INSIDE PATIENT. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. PROCEDURE FINISHED WITH COMPETITOR DEVICE. NO PATIENT COMPLICATIONS REPORTED. 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 11722134 ↗
  • MalfunctionJan 30, 2018Overheating of Device

    IT WAS REPORTED THAT THE DYONICS UNIT OVERHEATED. THERE WAS NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7228508 ↗

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.