Skip to content

DYONICS POWERMAX ELITE 72200616Recalls & reported problems

Smith & Nephew, Inc. · DYONICS POWERMAX ELITE HANDPIECE WITH BLADE MULTI-POSITIONING, HAND CONTROLS, SUCTION LEVER, 10 FT 3 M CORD · Class 1

Quick summary

This Smith & Nephew Dyonics PowerMAX Elite is a powered surgical saw handpiece with accessories. Its 4,304 adverse event reports mostly describe overheating, mechanical jams and unusual noise, and some describe burns. The reports include no deaths and 31 injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
4,290
Deaths reported
0
Injuries reported
31
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4,290 adverse event reports that list this exact device (DI 03596010555472), received between Aug 14, 2017 and Jun 30, 2026 — classified as 31 injuries, 4,259 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (2,520 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.

Reports received per month

Nov 2023: 59 reportsDec 2023: 41 reportsJan 2024: 62 reportsFeb 2024: 38 reportsMar 2024: 53 reportsApr 2024: 64 reportsMay 2024: 56 reportsJun 2024: 40 reportsJul 2024: 27 reportsAug 2024: 22 reportsSep 2024: 5 reportsOct 2024: 17 reportsNov 2024: 24 reportsDec 2024: 17 reportsJan 2025: 15 reportsFeb 2025: 15 reportsMar 2025: 22 reportsApr 2025: 10 reportsMay 2025: 14 reportsJun 2025: 8 reportsJul 2025: 16 reportsAug 2025: 10 reportsSep 2025: 13 reportsOct 2025: 24 reportsNov 2025: 15 reportsDec 2025: 14 reportsJan 2026: 13 reportsFeb 2026: 16 reportsMar 2026: 16 reportsApr 2026: 10 reportsMay 2026: 11 reportsJun 2026: 4 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202664
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Overheating of Device2,520
  • Mechanical Jam1,391
  • Mechanical Problem367
  • Protective Measures Problem254
  • Insufficient Device Problem Information172
  • Noise, Audible151
  • Electrical Shorting64
  • Physical Resistance/Sticking53

Patient problems

  • No Clinical Signs, Symptoms or Conditions2,897
  • No Patient Involvement635
  • No Known Impact Or Consequence To Patient633
  • No Information93
  • No Consequences Or Impact To Patient28
  • Burn(s)7
  • Insufficient Information5
  • Partial thickness (Second Degree) Burn4

Recent adverse event reports

The 25 most recent of 4,290 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 30, 2026Overheating of Device

    IT WAS REPORTED THAT ONE (1) MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL WAS RUNNING HOT. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED. HOWEVER, THERE WAS NO DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25662320 ↗
  • MalfunctionJun 28, 2026Overheating of Device

    IT WAS REPORTED THAT, MDU WAS OVERHEATING WHEN USED. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25648552 ↗
  • MalfunctionJun 1, 2026Overheating of Device

    IT WAS REPORTED THAT, BEFORE A SURGERY, THE MDU WAS OVERHEATING. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25356468 ↗
  • MalfunctionJun 1, 2026Mechanical Jam

    IT WAS REPORTED THAT, BEFORE A KNEE ARTHROSCOPY, IT WAS NOTICED THAT A MOTOR DRIVE UNIT MALFUNCTIONED IMMEDIATELY UPON STARTING AND THERE WAS NO SOLUTION. TESTS WERE PERFORMED AND THE DEVICE WAS RESTARTED MULTIPLE TIMES BUT NOTHING WORKED. THE CONTROLLER DISPLAYED "BLADE JAMMED". THE PROCEDURE WAS PERFORMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING THE BASKET AND THE 90° HANDPIECE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25352869 ↗
  • MalfunctionMay 31, 2026Overheating of Device

    IT WAS REPORTED THAT THE MDU WAS BROKEN, GOT WARM. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25341660 ↗
  • MalfunctionMay 27, 2026Overheating of Device

    IT WAS REPORTED THAT, AN UNKNOWN HANDPIECE WAS FAULTY AND GOT WARM WHEN TRYING TO USE IT. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25311092 ↗
  • MalfunctionMay 26, 2026Overheating of Device

    IT WAS REPORTED THAT, THERE WAS ABNORMAL HEATING OBSERVED ON A MOTOR DRIVE UNIT. AS THIS WAS NOTICED UPON ROUTINE INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25295337 ↗
  • MalfunctionMay 18, 2026Overheating of Device

    IT WAS REPORTED THAT THE MDU WAS GETTING HOT. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25202264 ↗
  • MalfunctionMay 15, 2026Activation Failure

    IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY, ONE (1) MDU WAS STOPPED WORKING. THE PROCEDURE WAS RESUMED, AFTER A 40 MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25185174 ↗
  • MalfunctionMay 14, 2026Electrical /Electronic Property Problem; Overheating of Device; Mechanical Jam

    IT WAS REPORTED THAT, DURING SURGERY, AN MDU OVERHEATED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25175290 ↗
  • MalfunctionMay 11, 2026Mechanical Problem; Overheating of Device; Mechanical Jam; Noise, Audible

    IT WAS REPORTED THAT, BEFORE A ROTATOR CUFF REPAIR, IT WAS NOTICED THAT ONE (1) MOTOR DRIVE UNIT WAS NOT FUNCTIONING CORRECTLY. THE MDU FREQUENTLY JAMMED, EMITTED AN UNUSUAL NOISE AS IF THE MOTOR WERE BEING STRAINED, DID NOT OSCILLATE CORRECTLY, AND OVERHEATED. THE PROCEDURE WAS PERFORMED, AFTER 1-HOUR DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25145213 ↗
  • MalfunctionMay 11, 2026Electrical /Electronic Property Problem; Mechanical Problem; Overheating of Device

    IT WAS REPORTED THAT THE MDU WAS OVERHEATING. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25142742 ↗
  • MalfunctionMay 11, 2026Overheating of Device

    IT WAS REPORTED THAT THE MDU BECAME VERY HOT DURING USE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25136304 ↗
  • MalfunctionMay 5, 2026Electrical /Electronic Property Problem; Overheating of Device; Mechanical Jam; Unexpected Shutdown

    IT WAS REPORTED THAT THE MDU WENT DOWN AND WAS OVER HEATING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25089768 ↗
  • MalfunctionMay 3, 2026Device Alarm System; Overheating of Device

    IT WAS REPORTED THAT BEFORE A MENISECTOMY, WHEN CONNECTING THE MDU TO THE CONSOLE, IT BEGAN TO HEAT UP AND SUBSEQUENTLY TRIGGERED A HANDPIECE MALFUNCTION ALARM. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS NO DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25063072 ↗
  • MalfunctionApr 29, 2026Electrical /Electronic Property Problem; Mechanical Problem; Overheating of Device

    IT WAS REPORTED THAT, BEFORE A SURGERY, THE MDU OVERHEATED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25024316 ↗
  • MalfunctionApr 28, 2026Overheating of Device; Noise, Audible

    IT WAS REPORTED THAT AN MDU MOTOR HAD A NOISY SOUND AND WAS OVERHEATING. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25024202 ↗
  • MalfunctionApr 19, 2026Overheating of Device

    IT WAS REPORTED THAT BEFORE A KNEE SCOPE PROCEDURE, ONE DYONICS POWERMAX ELITE HANDPIECE HEATED UP AND STOPPED WORKING. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24921351 ↗
  • MalfunctionApr 18, 2026Self-Activation or Keying

    IT WAS REPORTED THAT, DURING A KNEE SCOPE, ONE (1) MDU POWERMAX ELITE WAS RANDOMLY ACTIVATING WHEN THE BUTTONS OR THE FOOT PEDAL WASN'T BEING PRESSED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24919788 ↗
  • MalfunctionApr 16, 2026Overheating of Device; Mechanical Jam

    IT WAS REPORTED THAT, BEFORE A SHOULDER SURGERY, IT WAS NOTICED THAT ONE (1) MDU OVERHEATED AND DID NOT OSCILLATE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24905027 ↗
  • MalfunctionApr 13, 2026Overheating of Device; Mechanical Jam

    IT WAS REPORTED THAT, BEFORE A SHOULDER SURGERY, ONE (1) MOTOR DRIVE UNIT OVERHEATED AND DID NOT OSCILLATE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24860624 ↗
  • MalfunctionApr 8, 2026Overheating of Device; Electrical Shorting; Activation Failure; Noise, Audible

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE MDU EMITTED A LOUD NOISE AND BECAME HOT WHEN CONNECTED AND POWERED ON. WHEN ATTEMPTED TO BE USED AGAIN, THE DYONICS MACHINE DISPLAYED A ¿SHORT CIRCUIT DETECTED¿ ERROR MESSAGE, AND THE MDU COULD NOT BE POWERED ON. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24817614 ↗
  • MalfunctionApr 5, 2026Overheating of Device; Mechanical Jam

    IT WAS REPORTED THAT, BEFORE A SURGERY, IT WAS NOTICED THAT THE MOTOR DRIVE UNIT WAS OVERHEATING. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24786753 ↗
  • MalfunctionApr 3, 2026Overheating of Device

    IT WAS REPORTED THAT AN MDU BECAME VERY HOT. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED. NO FURTHER INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24776554 ↗
  • MalfunctionApr 1, 2026Melted; Overheating of Device

    IT WAS REPORTED THAT DURING A SHOULDER SURGERY, WHEN THE RPM OF ONE (1) MOTOR DRIVE UNIT WAS INCREASED TO 8,000¿10,000, HEAT BUILT UP INSIDE AND THE PLASTIC ON THE SHAVER BLADE MELTED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24754933 ↗

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.