CHS 110023Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010033192), received between Apr 22, 2021 and Apr 29, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2024Break; Break

  IT WAS REPORTED THAT, DURING A CHS PROCEDURE, THE LOCKING MECHANISM FOR THE DEPTH STOP OF ONE (1) POWER COMBINATION REAMER BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202556 ↗
• MalfunctionOct 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE TIP AND PART OF THE HANDLE OF A POWER COMBINATION REAMER BROKE OFF. SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905572 ↗
• MalfunctionApr 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE CONNECTION TO THE DRILL OF A POWER COMBINATION REAMER SNAPPED OFF DUE TO WEAR AND TEAR. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16764578 ↗
• MalfunctionMay 5, 2022Break; Break

  IT WAS REPORTED THAT A POWER COMBINATION REAMER BROKEN OFF FROM SHAFT. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285768 ↗
• MalfunctionNov 17, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR AN INTERNAL FIXATION SURGERY, A POWER COMBINATION REAMER WAS FOUND BROKEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833439 ↗
• MalfunctionJun 1, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, A POWER COMBINATION REAMER IS JAMMED ON TO AN OTHER COMPANY REAMER. AS THIS WAS NOTICED AFTER PROCEDURE, NO DELAY WAS REPORTED AND PATIENT WAS NOT IMPACTED BY THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916864 ↗
• MalfunctionMay 6, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A FEMORAL FRACTURE SURGERY, THE REAMER CHANNEL OF A POWER COMBINATION REAMER DID NOT ALLOW THE SMALL DIAMETER REAMER TO THE PASS THROUGH. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED AS A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO PATIENT INJURY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784132 ↗
• MalfunctionApr 22, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT UPON INSPECTION WAS FOUND THAT A POWER COMBINATION REAMER (CASE-(B)(4)) DOES NOT TIGHTEN PROPERLY AND A COMBINATION DRILL GUIDE 3.5M (CASE-(B)(4)) IS STUCK. NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711042 ↗