NA 352.095Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10886982194190), received between Jan 11, 2018 and Sep 4, 2026 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (37 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615983 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615352 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614242 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613483 ↗
• MalfunctionSep 2, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568798 ↗
• MalfunctionApr 29, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE IN 2025, ALL REAMING HEADS IN THE SYNREAM SET WERE BLUNT AND NOT WORKING WELL DURING A TIBIAL NAIL. IT TOOK THE SURGEON LONGER TO REAM. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE-MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927080 ↗
• 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 Ø9.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238110 ↗
• 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) AND (B)(4) ARE RELATED TO THE EVENT. THIS REPORT INVOLVES ONE SYNREAM REAMER HEAD Ø9.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237233 ↗
• MalfunctionNov 30, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT CLINICAL RESOURCE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS ARE DULL. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 9.5MM MEDULLARY REAMER HEAD THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242843 ↗
• MalfunctionNov 30, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT CLINICAL RESOURCE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS ARE DULL. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 9.5MM MEDULLARY REAMER HEAD THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242401 ↗
• MalfunctionNov 30, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT CLINICAL RESOURCE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS ARE DULL. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 9.5MM MEDULLARY REAMER HEAD THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241742 ↗
• MalfunctionNov 30, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT CLINICAL RESOURCE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS ARE DULL. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 9.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 7 OF 10 FOR COMPLAINT PC-(B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINTS PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239844 ↗
• MalfunctionNov 27, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON OCTOBER 27, 2023, THE REAMER HEADS WERE DULL WHICH CAUSED ADDITIONAL PASSES THROUGH THE IM CANAL. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) 9.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 3 OF 10 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209210 ↗
• MalfunctionNov 16, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON 27-OCTOBER-2023, THE REAMER HEADS IN QUESTION WERE FOUND TO BE DULL. THEY REQUIRED ADDITIONAL PASSES THROUGH THE IM CANAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 1 MINUTE. NO FRAGMENTS WERE GENERATED. NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 9.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149845 ↗
• MalfunctionAug 11, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THAT DURING THE REAMING PROCESS IN A TIBIAL NAIL ADVANCE CASE, THE REAMING ROD WAS REMOVED TO GRAB A FRESH ONE AND THE FIRST ONE WAS ABANDONED. WHILE GRABBING THE SECOND REAMING ROD, THE DOCTOR STARTED TO MEAN FOR THE REFLEX NEW REAMING SYSTEM WITHOUT THE REAMING ROD, THE TIP OF THE REAMER HEAD FELL OFF IN THE PATIENT CANAL. AS A RESULT, A HOLE WAS DRILLED IN THE TIBIAL SHAFT USING THE REAMING ROD RETROGRADE KIND THAT REAMER HEAD AND IT WAS REMOVED THROUGH THE OPENING OF THE CANAL. THERE WAS SURGICAL DELAY OF 15-20 MINUTES EVERYTHING ELSE IN THE CASE WAS SMOOTH AFTER THE SUCCESSFUL REMOVAL. IT WAS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES/OUTCOME. CONCOMITANT PRODUCT DETAILS: UNK - NAILS: TIBIAL (PART # UNKNOWN, LOT # UNKNOWN, QTY - UNKNOWN). THIS REPORT IS FOR ONE (1) UNK - REAMING RODS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17513359 ↗
• 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 9.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 3 OF 21 FOR (B)(4).YO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479583 ↗
• MalfunctionOct 17, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING ROUTINE PROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THE REAMER HEADS IN QUESTION HAD BECOME DULL AND WERE NO LONGER USEFUL IN PERFORMING THEIR PRIMARY FUNCTION. THESE ITEMS WERE DISCARDED AND REPLACEMENTS WERE REQUESTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 9.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 11 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620507 ↗
• MalfunctionOct 17, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING ROUTINE PROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THE REAMER HEADS IN QUESTION HAD BECOME DULL AND WERE NO LONGER USEFUL IN PERFORMING THEIR PRIMARY FUNCTION. THESE ITEMS WERE DISCARDED AND REPLACEMENTS WERE REQUESTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 9.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620498 ↗
• MalfunctionSep 20, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE REAMER HEADS WERE DULL. THEY WERE NO LONGER CUTTING THROUGH BONE PROPERLY. SURGERY WAS DELAYED 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 9.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 3 OF 14 FOR COMPLAINT (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457074 ↗
• MalfunctionSep 19, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE REAMER HEADS IN QUESTION WERE FOUND TO BE DULL AND WOULD NO LONGER CUT THROUGH BONE PROPERLY. SURGERY WAS DELAYED FOR 5 MINUTES BUT WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT OUTCOME. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 9.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15450385 ↗
• MalfunctionAug 31, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE SYNREAM REAMER HEADS WERE FOUND WITH WEAR AND TEAR AND REQUIRE REPLACING. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 9.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15330274 ↗
• MalfunctionJul 21, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED ON (B)(6) 2022, THE REAMER HEADS WERE DULL. THEY DO NOT CUT THROUGH BONE EFFICIENTLY ANYMORE. SURGERY WAS DELAYED 5 MINUTES DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 9.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 14 OF 20 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075118 ↗
• MalfunctionJul 21, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED ON (B)(6) 2022, THE REAMER HEADS WERE DULL. THEY DO NOT CUT THROUGH BONE EFFICIENTLY ANYMORE. SURGERY WAS DELAYED 5 MINUTES DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 9.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 3 OF 20 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074543 ↗
• MalfunctionDec 1, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021 SYNREAM, REAMER HEADS WERE SO BLUNT THAT THEY COULD NOT REAM THE CANAL OF THE PATIENT. SURGEON SUBSEQUENTLY OPENED THE HUMERAL REAMER SET WHICH WAS VERY SHARP AND EASILY PASSED THROUGH THE CANAL. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 9.5 MM MEDULLARY REAMER HEAD. THIS IS REPORT 3 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910454 ↗
• MalfunctionNov 30, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021 SYNREAM REAMER HEADS WERE SO BLUNT THAT THEY COULD NOT REAM THE CANAL OF THE PATIENT. SURGEON SUBSEQUENTLY OPENED THE HUMERAL REAMER SET WHICH WAS VERY SHARP AND EASILY PASSED THROUGH THE CANAL. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 9.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 4 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12897196 ↗