POWEREASE™ Instruments 2342306SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994905581), received between Jul 13, 2019 and Apr 1, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PRODUCT USED DURING SPINAL FUSIONS TO INSERT PEDICLE SCREWS. IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS BROKEN. THIS DID NOT OCCUR DURING A CASE AND WAS NOT ASSOCIATED WITH A PATIENT. THE PATIENT INVOLVEMENT IN THE EVENT IS UNKNOWN AND HENCE NO FRAGMENT OF THE INSTRUMENT REMAINED IN A PATIENT. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21736705 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT BOTH DRIVERS BROKEN. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301046 ↗
• MalfunctionNov 9, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN LUMBAR FUSION. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THIS EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15757978 ↗
• MalfunctionDec 2, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR SCOLIOSIS/REVISION. IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE OFF WHEN SURGEON TRYING TO REMOVE A SOLERA SCREW. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS FUSION. THE PRODUCT CAME IN CONTACT WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12915736 ↗
• MalfunctionNov 30, 2021Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. IT WAS REPORTED THAT THE PATIENT HAD MEDICAL HISTORY OF SCOLIOSIS. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12889168 ↗
• 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 10600506 ↗
• MalfunctionApr 13, 2020Break; Break

  IT WAS REPORTED THAT INTRA-OP, THE SCREWDRIVER TIP BROKE OFF WHILE INSERTING SCREW TO A VERY HARD PATIENT BONE. IT OCCURRED DURING WHILE INSERTING SCREW IN VERY HARD PATIENT BONE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9953972 ↗
• MalfunctionJul 13, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION. INTRA-OP, SCREWDRIVER WAS FOUND TO BE TWISTED WHEN SCREWS WERE BEING IMPLANTED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8787447 ↗

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.