POWEREASE™ Instruments 2342301SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994905673), received between Sep 29, 2020 and Apr 22, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

2 other recalls 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionApr 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING THE INSTRUMENTS USED FOR REVISION SURGERY. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN. THERE WAS NO PATIENT INVOLVED AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881183 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING THE INSTRUMENTS USED FOR REVISION SURGERY. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN. THERE WAS NO PATIENT INVOLVED AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187930 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING THE INSTRUMENTS USED FOR TLIF THERAPY. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN. THERE WAS NO PATIENT INVOLVED AT THE TIME OF EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187839 ↗
• MalfunctionSep 29, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH DEGENERATIVE DISC DISEASE FOR POSTERIOR SPINAL FUSION (PSF). IT WAS REPORTED THAT INTRA-OPERATIVELY, A T25 SET SCREW NEEDED TO BE REMOVED AFTER BREAKING OFF. UNFORTUNATELY, THERE WAS NO T25 REMOVAL TOOL IN THE SOLERA INSTRUMENT TRAY. THE T25 FROM THE USR WAS NOT AVAILABLE IN THE SET. SURGEON NEEDED TO USE THE DRIVERS TO REMOVE THE SETSCREW TO ADJUST THE CONSTRUCT, AFTER BREAKING TWO DRIVERS SURGEON WAS SUCCESSFUL WITH THE THIRD DRIVER. THE PRODUCTS WERE NOT UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THE PRODUCTS DID NOT COME IN CONTACT WITH THE PATIENT. THERE WERE NO FRAGMENT OF THE IMPLANT, OR INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS, OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10600627 ↗

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-2461-2025 · Jul 17, 2025 · Open, Classified
  IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments
• Z-0952-2015 · Dec 3, 2014 · Terminated
  POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.