POWEREASE InstrumentsRecalls & reported problems across all models

We found 8 models of POWEREASE Instruments by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 331 adverse event reports in the FDA's MAUDE database, received between Dec 22, 2016 and Sep 28, 2026 — classified as 2 injuries, 329 malfunctions.

The most frequently reported specific device problem is “Break” (112 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

POWEREASE Instruments recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 17, 2025Open, Classified

   Due to out of the box wobble of the driver.

   Z-2461-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported POWEREASE Instruments problems

POWEREASE Instruments models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• POWEREASE™ Instruments 2300000

  STIMULATOR, ELECTRICAL, EVOKED RESPONSE
  1 recall203 reports
• POWEREASE™ Instruments 2342306M

  INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
  80 reports
• POWEREASE™ Instruments 2342281M

  INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
  19 reports
• POWEREASE™ Instruments 2342306S

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  8 reports
• POWEREASE™ Instruments 2342301M

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  8 reports
• POWEREASE™ Instruments 2342305M

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  8 reports
• POWEREASE™ Instruments 2342301S

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  4 reports
• POWEREASE™ Instruments 2343431M

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  1 report

Recent POWEREASE Instruments adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Vibration

  It was reported that Powerease was wobbling and when using it becomes locked. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913695 ↗
• MalfunctionSep 24, 2026Excessive Heating

  It was reported that pre op, the powerease was overheating. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50879954 ↗
• MalfunctionSep 15, 2026Overheating of Device

  It was reported that pre-op, Powerease was overheating. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769592 ↗
• MalfunctionJun 12, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE RETURNED FOR PLANNED MAINTENANCE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481591 ↗
• MalfunctionMay 14, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE POWEREASE DEVICE REQUIRES AN EVALUATION CHECK. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25169250 ↗
• MalfunctionApr 17, 2026Self-Activation or Keying

  IT WAS REPORTED THAT DURING PRE-OP OF LUMBAR FUSION, THE POWEREASE HANDPIECE MOTOR CONTINUES TO SPIN WHEN ACTIVATION TRIGGER WAS REL EASED. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906527 ↗
• MalfunctionApr 13, 2026Overheating of Device

  IT WAS REPORTED THAT INTRA OP, DEVICE POPPED SMOKE. THERE IS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24858421 ↗
• MalfunctionApr 10, 2026Self-Activation or Keying; Noise, Audible

  IT WAS REPORTED THAT DEVICE RUNS CONTINUOUSLY AND WAS NOISY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24841894 ↗
• MalfunctionApr 8, 2026Overheating of Device

  IT WAS REPORTED THAT PRE-OP, THE POWEREASE HANDPIECE WAS OVERHEATING. IT WAS USED 2-3 TIMES AT THE START OF THE CASE BUT TOTAL RUNNING TIME OF LESS THAN ONE MINUTE. THE DEVICE WAS USED AT NORMAL SPEED IN FORWARD MODE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24812660 ↗
• MalfunctionApr 7, 2026Excessive Heating

  IT WAS REPORTED THAT PRE-OP, THE DEVICE WAS OVERHEATING IN LESS THAN A MINUTE. THE DEVICE WAS RUN AT FORWARD MODE AT NORMAL FORWARD SPEED WITHOUT ANY IRRIGATION. THE ISSUE WAS NOTICED DURING THE AWL TIP TAP TESTING AND A NEW STERILE ONE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797214 ↗
• MalfunctionApr 3, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE WAS RETURNED FOR PLANNED MAINTENANCE WITH NO ALLEGATION OF ANY DEVICE MALFUNCTION OR ADVERSE EVENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777027 ↗
• MalfunctionMar 23, 2026Break; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT POST-OP, POWEREREASE WAS NOT WORKING PROPERLY, IT WAS MAKING A GRINDING NOISE, AND IT HEATS UP QUICKLY. HANDPIECE WAS RUNNING AT 120RPM IN FORWARD MODE AND NO IRRIGATION WAS BEING USED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660456 ↗
• MalfunctionMar 20, 2026No Apparent Adverse Event

  THE POWEREASE WAS SENT IN FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647245 ↗
• MalfunctionMar 18, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT, THE DRIVER WAS STRIPPED WITH CORRECT USAGE UNDER TO STRONG FORCES. THORACIC PROBE WAS DROPPED DURING SURGERY AND THE TIP OF THE PROBE WAS DAMAGED AND DESCRIBED AS NON-USABLE FOR SURGERY. THE PROBE WAS DROPPED (UNINTENTIONALLY) AND IT MADE CONTACT WITH THE FLOOR DIRECTLY WITH THE TIP OF THE PROBE TO THE FLOOR, AND IT CREATED A SMALL DEFORMED AREA ON THE TIP OF THE PROBE. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628995 ↗
• MalfunctionMar 17, 2026No Apparent Adverse Event

  POWEREASE WAS SENT IN FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615635 ↗

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