NA 309.200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982185679), received between May 24, 2021 and Mar 8, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2022Failure to Cut; Failure to Cut

  THE HOSPITAL REPORTED THAT THE SCREW EXTRACTION SET WAS USED FOR A CASE. THE SURGEON FOUND THAT THE HOLLOW REAMER (309.200) WAS VERY BLUNTED AND DIDN¿T PERFORM AS EXPECTED. THIS DIDN¿T DELAY THE CASE OR CAUSE ANY HARM TO THE PATIENT AS THEY HAD AN ALTERNATIVE OPTION TO USE ON THE SHELF. THIS COMPLAINT INVOLVES ONE (1) DEVICES HOLLOW-REAMER-COMPL ANTICLOCKWISE CUTTIN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694536 ↗
• MalfunctionMay 24, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A HARDWARE REMOVAL OF AN UNKNOWN PROXIMAL FEMUR PLATING CONSTRUCT, A COUPLE OF UNKNOWN SCREW REMOVAL EXTRACTORS WERE BROKEN AND DAMAGED. ALL BROKEN PIECES WERE SUCCESSFULLY REMOVED. THERE WAS UNKNOWN SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR (1) HOLLOW REAMER-COMPLETE FOR 2.0MM SCREWS. THIS REPORT IS 6 OF 6 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870513 ↗