NA 352.115Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10886982194237), received between Aug 17, 2017 and Sep 4, 2026 — classified as 2 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (34 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 48 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 50616077 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614392 ↗
• MalfunctionSep 2, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569074 ↗
• 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 21927083 ↗
• 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 Ø11.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238465 ↗
• 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 Ø11.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237266 ↗
• MalfunctionJul 18, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON JUNE 22, 2024, THE REAMER WAS DULL DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THE ISSUE WAS NOTICED PREOPERATIVELY. THIS REPORT INVOLVES ONE 11.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19770722 ↗
• MalfunctionJul 18, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON JUNE 22, 2024, THE REAMER WAS DULL DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THE ISSUE WAS NOTICED PREOPERATIVELY. THIS REPORT INVOLVES ONE 11.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19770589 ↗
• MalfunctionNov 30, 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, THE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAY WERE DULL. REPLACEMENTS WERE REQUIRED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 11.5MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4) AND (B)(4) , WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237567 ↗
• MalfunctionNov 30, 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, THE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAY WERE DULL. REPLACEMENTS WERE REQUIRED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 11.5MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4) AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237564 ↗
• MalfunctionNov 30, 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, THE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAY WERE DULL. REPLACEMENTS WERE REQUIRED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 11.5MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4) AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237560 ↗
• MalfunctionNov 30, 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, THE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAY WERE DULL. REPLACEMENTS WERE REQUIRED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 11.5MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4) AND (B)(4) , WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237558 ↗
• 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) 11.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 7 OF 10 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209189 ↗
• 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) 11.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 9 OF 10 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209171 ↗
• InjuryJul 24, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING A TROCHANTERIC FIXATION NAIL - ADVANCED (TFNA) PROCEDURE, ALONG WITH THE SYNREAM MEDULLAR SHAFT HAD BROKEN INSIDE THE PATIENT'S FEMUR DURING THE REAMING STAGE. THE SURGEON PROCEEDED TO CUT THE CURRENT GUIDE WIRE IN THE SHAFT AT THE SITE OF THE FRACTURE, REMOVING IT, THEN USING A NEW BALL TIP GUIDE WIRE TO REMOVE THE METAL FRAGMENTS THROUGH A CREATED OPEN INCISION. THE SURGEON WAS ABLE TO REMOVE THE FRAGMENTS WITH THIS STRATEGY APPROXIMATELY 45 MINUTES AFTER OBSERVING THE BROKEN REAMER, BUT WAS QUITE UPSET WITH THE DEVICE MALFUNCTION. ONCE REMOVING 3/4 FRAGMENTS USING X-RAYS, LEAVING A SMALL FRAGMENT IN THE FEMUR, THE SURGEON CONTINUED WITH THE TFNA PROCEDURE ACCORDING TO THE PLAN AND SUCCESSFULLY CLOSED WITHIN THE NEXT HOUR WITH AN 11/360MM NAIL AND AN 85MM BLADE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 45 MINUTES OF SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 11.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17379777 ↗
• MalfunctionJan 10, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 WHILE REAMING FEMORAL CANAL, THE REAMER HEAD SPLIT INTO TWO PIECES AND THE SHAFT OF THE REAMING SHAFT BROKE.. THE FRAGMENTS WERE REMOVE FROM THE FEMUR AND SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS SURGICAL DELAY OF 15 MINUTES. AND NO PATIENT CONSEQUENCES ARE THERE. THIS COMPLAIN INVOLVES TWO(2) DEVICE. THIS REPORT IS FOR ONE (1) 11.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134310 ↗
• MalfunctionOct 17, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM (B)(6) 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 11.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 6 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620501 ↗
• 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 11.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 15 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620455 ↗
• 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) 11.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457456 ↗
• 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) 11.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 7 OF 14 FOR COMPLAINT (B)(4). THIS PRODUCT COMPLAINT, (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457352 ↗
• 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 11.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331029 ↗
• 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) 11.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 18 OF 20 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075252 ↗
• 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) 11.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 7 OF 20 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074685 ↗
• MalfunctionMay 25, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: THIS IS REPORT 5 OF 7 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN COLOMBIA THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE REAMER DEVICE WAS DULL TO MAKE CUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14500406 ↗
• MalfunctionMay 7, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE INTRAMEDULLARY INSERTION SURGERY USING ETN FOR TIBIAL SHAFT FRACTURE WITH THE MEDULLARY REAMER HEAD IN QUESTION. IN THE SURGERY, THE K-WIRE WAS USED AS BLOCKER PIN TO GUIDE THE INSERTION POSITION OF THE REAMING ROD. THE REAMING HEAD CONTACTED WITH THE BLOCKING PIN DURING REAMING, AND THE CUTTING EDGE WAS WORN. NO RESIDUE WAS FOUND IN THE BODY, AND THE SURGERY WAS CONTINUED AT THE DISCRETION OF THE SURGEON. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) SYNREAM REAMER HEAD Ø11.5 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316548 ↗