CHS 110075Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010033697), received between Apr 23, 2021 and Nov 11, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2021Break; Break

  IT WAS REPORTED THAT, A COMBINATION DRILL GUIDE 3.5MM BROKE OFF WHILE OUTSIDE THE PATIENT, DURING CHS PROCEDURE. SURGERY WAS COMPLETED WITH A BACKUP DEVICE, WITHOUT ANY DELAY. NO PIECES FELL INTO PATIENT AND THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12799917 ↗
• MalfunctionOct 8, 2021Break; Break

  IT WAS REPORTED THAT ONE COMBINATION DRILL GUIDE 3.5MM SHEARED AT ONE END. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599407 ↗
• MalfunctionApr 23, 2021Mechanical Jam; Mechanical Jam

  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 11716045 ↗