POWEREASE™ Instruments 2342305MRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994905697), received between Sep 15, 2017 and Dec 4, 2025 — classified as 8 malfunctions.

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

• MalfunctionDec 4, 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 SCREWDRIVERS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713311 ↗
• MalfunctionDec 2, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING DRIVERS USED FOR SPINAL THERAPY. IT WAS REPO RTED THAT TWO SCREW DRIVERS WERE BROKEN. NO FRAGMENTS REMAINED IN THE PATIENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692814 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGOING UNKNOWN SPINE SURGERY FOR REMOVAL OF HARDWARE. IT WAS REPORTED THAT TIP OF THE INSERTER BROKEN OFF IN THE HEADOF THE SET SCREW. LEVELS IMPLANTED L3-L5. NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT BOTH SCREW DRIVERS BROKE DURING THE REMOVAL OF HARDWARE, PROCEDURE USED IN THIS EVENT WAS ADJACENT L2-3 TLIF FOR REMOVAL OF L3-5 HARDWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21302033 ↗
• MalfunctionJan 30, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING HARDWARE REMOVAL FROM PREVIOUS SURGERY. IT WAS REPORTED THAT THE DRIVERS BROKE WHILE REMOVING HARDWARE FROM PREVIOUS SURGERY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21271375 ↗
• MalfunctionDec 27, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY, SPD STAFF MEMBER) REGARDING A DRIVER USED TO IMPLANT PEDICLE SCREWS. IT WAS REPORTED THAT THE SCREWDRIVER WAS GIVEN TO A STAFF MEMBER BY SPD STAFF, WHO SHOWED THE PIECE THAT WAS COMING OFF. PRODUCT WAS USED MANY TIMES PRIOR TO THIS CASE WITH NO PROBLEM. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026017 ↗
• MalfunctionNov 2, 2020Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, USER FACILITY) REGARDING A PATIENT HAD PREVIOUS FUSION (TLIF). IT WAS REPORTED THAT THE BONE WAS HARD AND THE DRIVER SHEARED OFF WHEN DOCTOR TRIED TO UPSIZE THE SCREW. THE PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10768376 ↗
• MalfunctionJul 23, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PLIF (POSTERIOR LUMBAR INTERBODY FUSION) SURGERY DUE TO LUMBAR POSTERIOR LAMINECTOMY SYNDROME. INTRA-OP, THE TIP OF THE DRIVER BROKE. THE TIP WAS REMOVED FROM THE PATIENT BODY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8814918 ↗
• MalfunctionSep 15, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WITH DEGENERATIVE DISC DISEASE UNDERWENT UNSPECIFIED SPINAL PROCEDURE AT LEVELS L2-S1. INTRA-OP, AS THE SURGEON WAS ADVANCING THE SCREW, THE TIP OF THE DRIVER BROKE OFF INTO THE HEAD OF THE SCREW. NO FRAGMENTS REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6867791 ↗

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.