NA 352.170Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982194343), received between Mar 6, 2023 and Mar 4, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (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.

• MalfunctionMar 4, 2026Failure to Cut

  IT WAS REPORTED ON (B)(6) 2026, THAT UPON INSPECTION OF A NEW FLEXIBLE REAMER PAN, 3 REAMERS WERE FOUND TO BE DULL, AND THE COUPLING MECHANISM WAS MALFUNCTIONING (POPS OFF REAMER SHAFT). THIS WAS BEFORE ANY CASES WERE PERFORMED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505552 ↗
• MalfunctionMar 6, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING INTERMEDULLARY NAILING OF FEMUR ON (B)(6) 2023, THE REAMER HEADS FROM THE FLEXIBLE REAMER SET WERE REPORTED AS VERY DULL WHEN ATTEMPTING TO PASS REAMERS DOWN A FEMORAL CANAL. THE DULL REAMER HEADS CREATED MORE DIFFICULTY AND STRESS FOR THE SURGEON TO REAM PROPERLY. AFTER THE CASE, THE STAFF DISCARDED ALL OF THE REAMER HEADS IN THE SET BECAUSE OF THEIR DULLNESS. THERE WAS NO SURGICAL DELAY BECAUSE OF THE EVENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FRAGMENTS GENERATED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 17.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16488657 ↗