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NA 72200617FRecalls & reported problems

Smith & Nephew, Inc. · DYONICS POWERMAX ELITE HANDPIECE WITH BLADE MULTI-POSITIONING, NO HAND CONTROLS, SUCTION LEVER, 10 FT 3 M CORD REFURBISHED · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010608956), received between Jul 12, 2020 and Jul 12, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (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.

Most reported problems

Device problems

  • Mechanical Jam1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 12, 2020Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT THE MOTOR DRIVE UNIT SHAVER HANDLE WAS NOT WORKING WHEN PLUGGED IN. NO CASE INVOLVED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A BLADE STALL AND WAS NOT RUNNING WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Patient Involvement

    MAUDE report 10262240 ↗

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.