POWEREASE™ Instruments 2342306MRecalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00613994905727), received between Dec 22, 2016 and Mar 18, 2026 — classified as 1 injury, 79 malfunctions.

The most frequently reported specific device problem is “Break” (65 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionNov 3, 2025Degraded; Material Deformation; Degraded; Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT SCREWDRIVER WAS WORN AND STRIPPED. 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 23448976 ↗
• MalfunctionJun 9, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A SPINAL DECOMPRESSION AND FUSION PROCEDURE WITH PLACEMENT OF PEDICLE SCREWS IN A PATIENT DIAGNOSED WITH SPINAL STENOSIS. IT WAS REPORTED THAT THE SCREWDRIVER TIP SHEARED OFF DUE TO VERY HARD PATIENT BONE. THE DRIVER WAS UNDER A LOT OF TORQUE AND SNAPPED. THE TIP OF THE THORACIC PROBE TO REMOVE THE BROKEN PIECE OF THE SCREWDRIVER. AS A RESULT, THE PROBE TIP GOT BENT. THE BROKEN PIECE OF SCREWDRIVER WAS REMOVED AND DISCARDED. 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 22166250 ↗
• MalfunctionMay 27, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT AFTER SURGERY IT WAS NOTICED THAT THE TIP WAS BROKEN WHEN THE SET CAME OUT OF THE AUTOCLAVE. TIP WAS IN THE TRAY. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085324 ↗
• MalfunctionApr 29, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN SPINAL THERAPY FOR SPINAL STENOSIS. IT WAS REPORTED THAT THE PATIENT HAD VERY HARD BONE THAT PUT A LOT OF TORQUE ON THE SCREWDRIVER/SCREW INTERFACE. THE SCREWDRIVER TIP BROKE AS A RESULT. 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 21924340 ↗
• MalfunctionApr 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT WHILE REMOVING PREVIOUSLY FUSED HARDWARE, THE DRIVERS BROKE FROM EXTREME FORCE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS NO PATIENT INVOLVEMENT STRICTLY HARDWARE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771453 ↗
• MalfunctionApr 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT WHILE REMOVING PREVIOUSLY FUSED HARDWARE, THE DRIVERS BROKE FROM EXTREME FORCE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS NO PATIENT INVOLVEMENT STRICTLY HARDWARE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771398 ↗
• MalfunctionMar 2, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING DRIVERS IN A UNKNOWN SPINAL THERAPY FOR ADULT DEGENERATIVE SCOLIOSIS T5-PELVIS. IT WAS REPORTED THAT WHEN DRIVING A SCREW INTO THE PATIENT WITH DRIVERS, THE TIP OF THE SCREWDRIVERS BROKE OFF IN THE SCREW RECESS OF THE SCREW. THE DRIVERS HAD BEEN USED IN THE PAST AND BROKE AFTER REPEATED USE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21500925 ↗
• MalfunctionFeb 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR FUSION FOR DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT DURING THE PLACEMENT OF A LUMBAR SCREW THE TIP OF THE DRIVER BROKE OFF AND REMAINED STUCK IN THE TULIP PART OF THE SCREW. THERE WAS NO INJURY TO THE PATIENT DUE TO THE DRIVER TIP BREAKING OFF. THE PRODUCT WAS LOST. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21457003 ↗
• MalfunctionFeb 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT THE DRIVER BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442898 ↗
• MalfunctionFeb 21, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED FOR TRANSFORAMINAL LUMBAR INTER BODY FUSION AND OBLIQUE LATERAL INTERBODY FUSION. IT WAS REPORTED THAT THE INSTRUMENTS WERE 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 21429733 ↗
• MalfunctionFeb 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE INSTRUMENTS. IT WAS REP ORTED THAT INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394967 ↗
• MalfunctionFeb 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT WHILE REMOVING PREVIOUSLY FUSED HARDWARE, THE DRIVERS BROKE FROM EXTREME FORCE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS NO PATIENT INVOLVEMENT STRICTLY HARDWARE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392231 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREWDRIVER USED IN POSTERIOR SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE DEVICE BROKE. NO PATIENT WAS INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362253 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING A DRIVER USED IN A PSF. IT WAS REPORTED THAT THE DRIVER STRIPPED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVED AND THE DRIVER TIP BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21290189 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE DEVICE HAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21237079 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCTS. PRE-OP DIAGNOSIS OF PATIENT WAS PSEUDOARTHROSIS. MEDICAL HISTORY OF PATIENT INCLUDES SPINAL STENOSIS, PR IOR SPINAL FUSION. IT WAS REPORTED THAT, BROKEN TIP OF DRIVER LODGED IN HEAD OF SCREW, RENDERING IT UNUSABLE. THERE WAS NO FRAGMENT OF BROKEN DRIVER LEFT INSIDE THE PATIENT. SURGEON WAS ATTEMPTING TO IMPLANT A SIZE 8.5MM X 50MM DUAL ROD MULTI-AXIAL SCREW USING THE DRILL WITH DRIVER ATTACHMENT WHEN THE TIP OF THE DRIVER BROKE OFF IN THE SCREW. THERE WAS NO ALLEGATION/MALFUNCTION ASSOCIATED WITH PREVIOUSLY IMPLANTED HARDWARE. PATIENT DEVELOPED PSEUDARTHROSIS ABOVE PREVIOUS FUSION, THERE WAS NO ISSUE WITH THE SCREW, SURGEON WANTED TO REPOSITION. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187923 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING USE OF REPORTED PRODUCTS. IT WAS REPORTED THAT, THE TIP OF BOTH SCREWDRIVERS ARE BROKEN. THE TIPS BROKE OFF INTRA-OP, THEY ARE REMOVED FROM THE STERILE FIELD. THE EVENT WAS HAPPENED ON THE BACK TABLE BEFORE THE SURGERY STARTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187808 ↗
• MalfunctionJan 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT THAT WAS USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN, TORQUE LIMITING HANDLE WILL NOT TORQUE OUT AND SCREW FALLS OUT FROM DRIVER. THERE WAS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCTS WERE ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186277 ↗
• MalfunctionJan 13, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING INSTRUMENTS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT DRIVERS ARE BROKEN AND NEED TO BE REPLACED. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21134959 ↗
• MalfunctionDec 31, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DRIVERS USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVERS WERE STRIPPED. THE DEVICE WAS NOT RECEIVED AS FAULTY, AND THE PRODUCT HAS BEEN USED IN PRIOR PROCEDURES. 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 21047951 ↗
• MalfunctionDec 10, 2024Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT USED IN TRANSFORAMINAL LUMBAR INTER BODY FUSION (TLIF). IT WAS REPORTED THAT TIP OF DRIVER IS BENT AND NOT HOLDING SCREW STRAIGHT. NO PATINET WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATGIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20889355 ↗
• MalfunctionDec 9, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A SCREWDRIVER USED FOR S PINAL THERAPY. IT WAS REPORTED THAT THE SCREWDRIVER WAS STRIPPED WHILE LOADING THE SCREW. EVENT OCCURRED AT BACK TABLE. PRODUCT HAS BEEN USED IN PRIOR PROCEDURE. 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 20876999 ↗
• MalfunctionNov 26, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED FOR TLIF. IT WAS REPORTED THAT THE DEVICE HAS 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 20786482 ↗
• MalfunctionOct 11, 2024Naturally Worn; Naturally Worn

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE DRIVER TIP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20425522 ↗

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.