POWEREASE™ Instruments 2300000Recalls & reported problems
Medtronic Sofamor Danek, Inc. · DRIVER 2300000 POWEREASE · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Medtronic PowerEase driver has 200 adverse event reports, with no deaths and 1 injury. Many reports describe the handpiece vibrating, overheating, making noise, or continuing to spin after the trigger is released, and most report no effect on the patient. It has 1 recall, still open, started in July 2025, over the driver wobbling right out of the box. Reports rose to 81 in the last 12 months from 55 in the 12 months before.
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
- 203
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 203 adverse event reports that list this exact device (DI 00613994448705), received between Jun 27, 2018 and Sep 28, 2026 — classified as 1 injury, 202 malfunctions.
The most frequently reported specific device problem is “Vibration” (71 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K111520); they may or may not involve this specific model.
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
Recalls naming this device
- Jul 17, 2025Open, Classified
Due to out of the box wobble of the driver.
Z-2461-2025 · Root cause: Process change control · FDA record ↗
Most reported problems
Device problems
- No Apparent Adverse Event88
- Vibration71
- Overheating of Device20
- Noise, Audible12
- Self-Activation or Keying11
- Device Remains Activated10
- Use of Device Problem7
- Excessive Heating4
Patient problems
- No Clinical Signs, Symptoms or Conditions190
- No Consequences Or Impact To Patient8
- Insufficient Information5
- No Patient Involvement1
- Perforation of Vessels1
- Unintended Radiation Exposure1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 203 reports, 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 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 ↗MalfunctionMar 11, 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 24565905 ↗MalfunctionMar 9, 2026Excessive Heating
IT WAS REPORTED THAT DURING THE INTRA OPERATIVE PEDICLE SCREW PLACEMENT OR FINAL TIGHTENING THE POWEREASE WAS OVERHEATING. THE DEVICE WAS BEING RUN AT 120RPM IN FORWARD MODE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24543531 ↗MalfunctionMar 3, 2026Vibration
IT WAS REPORTED THAT DEVICE SENT PART OF FCA. THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494059 ↗MalfunctionFeb 25, 2026No Apparent Adverse Event
IT WAS REPORTED THAT INTRA OP, FALSE CONTACT REPEATED SEVERAL TIMES DURING A PROCEDURE. THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24438794 ↗MalfunctionFeb 22, 2026Vibration
IT WAS REPORTED THAT PRE-OP, THE DEVICE EXPERIENCED AN OUT-OF-BOX FAILURE DUE TO WOBBLING UPON UNBOXING, WHICH WAS CAUSED BY MISALIGNMENT BETWEEN THE QUICK CONNECT AND SHAFT MAIN DRIVER COMPONENTS. THERE IS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24411065 ↗MalfunctionFeb 20, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE DEVICE RETURNED FOR PM. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24398245 ↗MalfunctionFeb 4, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE DEVICE RETURNED FOR EVALUATION. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24259661 ↗MalfunctionFeb 4, 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 24257708 ↗MalfunctionFeb 4, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE POWEREASE WAS SENT FOR PLANNED MAINTENANCE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24256273 ↗MalfunctionFeb 4, 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 24256099 ↗MalfunctionFeb 4, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE DEVICE RETURNED FOR EVALUATION. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24255716 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K111520. One submission often covers many models, so check the product and lot details in each record.
- Z-0952-2015 · Dec 3, 2014 · TerminatedPOWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.