NA 352.155Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982194312), received between Sep 3, 2014 and Mar 3, 2023 — classified as 3 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. 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.

• MalfunctionMar 3, 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 15.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 14 OF 21 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479875 ↗
• MalfunctionJun 14, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR, WHILE THE SURGEON WAS REAMING THE FEMUR WITH A 15.5MM SYNTHES FLEXIBLE REAMER, THE REDUCTION WAS LOST AT THE FRACTURE SITE AND THE REAMER GOT STUCK IN THE CANAL. THE REAMER SHAFT WAS BROKEN. THE BALL TIP GUIDE WIRE HELD EVERYTHING AND THE BROKEN PIECES WERE REMOVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 15.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995416 ↗
• MalfunctionSep 3, 2014Corroded; Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 4054809 ↗