NA 352.090Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10886982194183), received between Jan 11, 2018 and Sep 4, 2026 — classified as 3 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (38 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 49 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 50615899 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615214 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614152 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613431 ↗
• MalfunctionSep 2, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568636 ↗
• MalfunctionDec 1, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN IT WAS IDENTIFIED THAT THE BODY OF THE REAMER HEAD IS DAMAGED. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681847 ↗
• MalfunctionAug 1, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON USED A REAMER HEAD DURING A TOTAL JOINT PROCEDURE AND IT WAS LEFT IN THE DISTAL FEMUR.

  Patient problems: Foreign Body In Patient

  MAUDE report 22687525 ↗
• 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 21927095 ↗
• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238119 ↗
• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236699 ↗
• 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) 9.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINTS (B)(4) &(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241556 ↗
• 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) 9.0MM MEDULLARY REAMER HEAD THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4) ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINTS (B)(4) & (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239710 ↗
• 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) 9.0MM MEDULLARY REAMER HEAD THIS IS REPORT 10 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 18239028 ↗
• 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) 9.0MM 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 18238986 ↗
• 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) 9.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 OF 10 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209248 ↗
• 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 (B)(6) 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 9.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149821 ↗
• 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. THIS REPORT IS FOR A 9.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 OF 21 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479580 ↗
• 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 9.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620495 ↗
• 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 9.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 10 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15619197 ↗
• 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) 9.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 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 15457067 ↗
• 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 9.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15450379 ↗
• 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 9.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15330286 ↗
• 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) 9.0MM MEDULLARY REAMER HEAD THIS IS REPORT 12 OF 20 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074909 ↗
• MalfunctionJul 21, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED ON JUNE 20 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) 9.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 OF 20 FOR COMPLAINT PC # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074505 ↗
• InjuryMay 31, 2022Break; Entrapment of Device; Device-Device Incompatibility; Break; Entrapment of Device; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE SUBTROCHANTERIC FRACTURE OF FEMUR WITH THE REAMER HEAD IN QUESTION. IN THE SURGERY, THE EVENT TOOK PLACE IN SEQUENCE AS FOLLOWS: THERE WAS AN INQUIRY ABOUT THE NAIL DIAMETER FROM THE SURGEON BEFORE SURGERY BECAUSE THE PATIENT HAD A NARROW MEDULLARY CAVITY, AND THE SALES REP RESPONDED THAT THERE WERE NAILS OF 9 MM OR LARGER. THE SURGEON CONFIRMED THAT THE PATIENT'S MEDULLARY CAVITY WAS 8 TO 9 MM BY CT, AND THEREFORE PLANNED TO PERFORM SUFFICIENT REAMING AND FIX WITH THE TFNA LONG NAIL. AT THE DISCRETION OF THE SURGEON WHO WANTED TO PERFORM MEDULLARY CAVITY REAMING FROM THE FRACTURED PART, THE FRACTURED PART WAS OPENED AND A GUIDE ROD WITH BALL TIP WAS INSERTED. THE SURGEON WAS UNABLE TO INSERT THE REAMING ROD FROM AROUND THE DISTAL 1/3 AND THE MEDULLARY CAVITY SEEMED TO BE BURIED. THE REAMING WAS ACHIEVED USING THE 8.5 MM REAMER HEAD TO THE DISTAL 1/3 WHERE THE REAMING ROD WAS INSERTED. HOWEVER, FURTHER DISTAL REAMING WAS NOT POSSIBLE. THE SALES REP LEFT THE OPERATING ROOM TO LOOK FOR ANOTHER INSTRUMENT FOR

  Patient problems: Foreign Body In Patient

  MAUDE report 14548605 ↗