NA 352.135Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982194275), received between Oct 20, 2021 and Sep 3, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589939 ↗
• MalfunctionSep 3, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589927 ↗
• MalfunctionSep 3, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589924 ↗
• MalfunctionSep 3, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589912 ↗
• MalfunctionSep 20, 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 Ø13.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20265835 ↗
• 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 Ø13.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237605 ↗
• MalfunctionNov 27, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 1, 2023, SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS WERE DULL. THERE WERE NO SURGICAL DELAYS OR PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 13.5MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208782 ↗
• MalfunctionNov 27, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 1, 2023, SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS WERE DULL. THERE WERE NO SURGICAL DELAYS OR PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 13.5MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208781 ↗
• MalfunctionNov 27, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 1, 2023, SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS WERE DULL. THERE WERE NO SURGICAL DELAYS OR PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 13.5MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208780 ↗
• MalfunctionNov 27, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 1, 2023, SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS WERE DULL. THERE WERE NO SURGICAL DELAYS OR PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 13.5MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208775 ↗
• MalfunctionOct 20, 2023Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A RIGHT FEMORAL TROCHANTERIC FRACTURE. THE SURGEON ATTEMPTED TO WIDEN THE MEDULLARY CAVITY USING A SYNREAM DEVICE BECAUSE A TFNA GOT STUCK AT THE DIAPHYSIS. THE REAMER HEAD CAME OFF WHEN THE SURGEON USED THE SYNREAM DEVICE WITHOUT A GUIDE ROD TO REAM. IT TOOK APPROXIMATELY 15 MINUTES TO REMOVE THE REAMER HEAD INSIDE THE MEDULLARY CAVITY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE SURGEON COMMENTED THAT THE PROBLEM WAS THAT HE USED SYNREAM DEVICE WITHOUT KNOWING THE CORRECT WAY TO USE IT. PATIENT STATUS/ OUTCOME: STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SYNREAM REAMER HEAD Ø13.5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17974685 ↗
• 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 13.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 10 OF 21 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479862 ↗
• 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) 13.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 11 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12667408 ↗