NA 352.145Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982194299), received between Jul 30, 2019 and Sep 17, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REAMER DID NOT CUT AND WAS FOUND TO BE DULL. THERE WAS NO PATIENT CONSEQUENCES. NO OTHER INFORMATION WAS PROVIDED. (B)(4) ARE RELATED TO THE EVENT. THIS REPORT INVOLVES ONE SYNREAM REAMER HEAD Ø14.5

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237645 ↗
• MalfunctionSep 17, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REAMER DID NOT CUT AND WAS FOUND TO BE DULL. THERE WAS NO PATIENT CONSEQUENCES. NO OTHER INFORMATION WAS PROVIDED. (B)(4) ARE RELATED TO THE EVENT. THIS REPORT INVOLVES ONE SYNREAM REAMER HEAD Ø14.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237510 ↗
• 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 14.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 12 OF 21 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479870 ↗
• MalfunctionOct 20, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING FIELD INVENTORY, THERE WERE (14) FOURTEEN REAMER HEADS THAT WERE DULL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 14.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 14 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12667860 ↗
• MalfunctionJul 30, 2019Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF INSTRUMENTS WHILE PUTTING THE SET BACK TOGETHER, THE TWO (2) MEDULLARY REAMER HEAD WERE NOTICED DULL TO THE TOUCH AND APPEARANCE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 14.5 MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8841934 ↗