NA 351.93Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982194060), received between May 10, 2021 and Jul 28, 2022 — classified as 2 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. 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.

• MalfunctionJul 28, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THE CASE WAS CONTAMINATED WITH BLOOD AND THE HAND REAMER WAS DAMAGED INTRAOPERATIVELY ON (B)(6) 2022. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A HAND REAMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122252 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE HAND - REAMER FOR MEDULLARY CANAL BROKE OFF INSIDE PATIENT¿S RIGHT TIBIA AND RETRIEVE THE PIECE WERE RETRIEVED. THERE WAS A SURGICAL DELAY OF APPROXIMATELY TWO (2) HOURS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT INVOLVES ONE (1) 7.0MM HAND REAMER 450MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798566 ↗