POWEREASE™ Instruments 2342281MRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00613994905604), received between Jan 3, 2018 and Feb 5, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL FUSION THERAPY. IT WAS REPORTED THAT BOTH THE INNER SLEEVES COMING OUT, AND THE DISTAL THREADS OF THE ELEVATE INNER SLEEVE BREAKING OFF. IT WAS CONFIRMED THAT NO FRAGMENT OF THE INSTRUMENT REMAINED IN THE PATIENT. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24266210 ↗
• MalfunctionFeb 5, 2026Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL FUSION THERAPY. IT WAS REPORTED THAT BOTH THE INNER SLEEVES COMING OUT, AND THE DISTAL THREADS OF THE ELEVATE INNER SLEEVE BREAKING OFF. IT WAS CONFIRMED THAT NO FRAGMENT OF THE INSTRUMENT REMAINED IN THE PATIENT. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24266179 ↗
• MalfunctionJul 10, 2025Break; Degraded; Break; Degraded

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS WORN AND BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22466089 ↗
• MalfunctionFeb 25, 2025Break; Naturally Worn; Break; Naturally Worn

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR SCOLIOSIS. IT WAS REPORTED THAT THE WELD BROKE ON THE SCREWDRIVER. THE DEVICE HAD NORMAL WEAR AND TEAR. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457044 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REAGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT DURING INSPECTION/CLEANUP AFTER A CASE THE TIP OF THE DRIVER CAME COMPLETELY OFF OF THE SHAFT OF THE DRIVER. IT CAN NOT BE ATTACHED AND NO LONGER CAN BE USED. NO PATIENT INVOLVED IN THIS EVENT. NO FUTHER COMPLICATIONS WERE REPORTED/ANTICIPATED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301890 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING TWO DRIVERS USED FOR PSF. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN. IT WAS NOT USED DURING PROCEDURE. FAILURE OF INSTRUMENT OCCURRED IN DEVICE FOLLOW UP. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301710 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT INSTRUMENT WAS BROKE DURING DEVICE FOLLOW UP AFTER PROCEDURE. NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301458 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER WELDING HAD CAME APART. THERE WAS NO PATIENT INVOLVED AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301071 ↗
• MalfunctionJan 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING INSTRUMENTS USED IN TLIF. IT WAS REPORTED THAT THE INSTRUMENTS WERE DAMAGED. THE ITEMS BECAME DAMAGED AND WORN OUT OVER TIME IN SPD. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21155710 ↗
• MalfunctionJan 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR T2-T12 PSF. IT WAS REPORTED THAT THE BROKEN DRIVER WAS DISCOVERED DURING CASE SET UP. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21132889 ↗
• MalfunctionJan 9, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING TWO DRIVERS USED FOR PSF. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN.  IT WAS NOT USED DURING PROCEDURE. FAILURE OF INSTRUMENT OCCURRED IN DEVICE FOLLOW UP. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111829 ↗
• MalfunctionJun 4, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER AND TIP HAD SEPARATED. THERE WAS NO PATIENT INVOLVED AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19456328 ↗
• MalfunctionMay 27, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT IT WAS NOTICED IN PRE OP AFTER SET WAS OPENED THAT DRIVER AND TIP HAD SEPARATED FROM EACH OTHER. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400112 ↗
• MalfunctionMay 24, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A SCREWDRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT  THE WELDED TIP PIECE HAD COME APART FROM THE DRIVER ITSELF. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT ONCE SET WAS OPENED FOR NEW CASE IT WAS BROKEN APART. PRODUCT HAD BEEN USED FOR MULTIPLE SURGERIES BEFORE COMING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19389601 ↗
• MalfunctionMay 22, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. NOTICED IN PRE OP THAT ONCE SET WAS OPENED AND PLACED ON STERILE FIELD THAT DRIVER TIP HAD SEPARATED FROM DRIVER. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371741 ↗
• MalfunctionApr 26, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR REMOVAL OF EXISTING HARDWARE. IT WAS REPORTED THAT THE SCREWDRIVER BROKE WHILE REMOVAL OF EXISTING HARDWARE. AT THIS POINT THE DRIVER WOULD NOT TURN AT BASE OF SCREW. ONLY SHAFT WOULD TURN. THIS DRIVER WAS PASSED OFF TO BACK TABLE AND 2ND IDENTICAL DRIVER ASSEMBLED TO SAME SCREW AND EXACT SAME THING HAPPENED. SURGEON REMOVED SCREWS SO THAT THERE WAS CONSISTENCY WITH THE SYSTEM IN THE PATIENT THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14201929 ↗
• MalfunctionAug 16, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCOLIOSIS SURGERY AT T11-L3. INTRA-OP, DURING SCREW INSERTION, THE WELD OF THE SCREWDRIVER CAME APART. NEW DRIVER WAS OPENED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7788376 ↗
• MalfunctionAug 16, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCOLIOSIS SURGERY AT T11-L3. INTRA-OP, DURING SCREW INSERTION, THE WELD OF THE SCREWDRIVER CAME APART. NEW DRIVER WAS OPENED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7788341 ↗
• MalfunctionJan 3, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH IDIOPATHIC SCOLIOSIS AND UNDERWENT SPINAL FUSION. DURING SURGERY, THE DRIVER BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7159574 ↗

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.