NA 352.125Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886982194251), received between Feb 28, 2017 and Sep 4, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (22 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 30 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 50616159 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615662 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614481 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613730 ↗
• MalfunctionSep 2, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569130 ↗
• 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 23681867 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025, THE REAMER HEAD BROKE OFF WHILE DOCTOR WAS SIZING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451409 ↗
• 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 Ø12.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238618 ↗
• 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 Ø12.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237369 ↗
• 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) 12.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 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 18240269 ↗
• 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) 12.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 6 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 18239796 ↗
• 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) 12.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 5 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 18239781 ↗
• 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) 12.5MM MEDULLARY REAMER HEAD THIS IS REPORT 4 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 18239775 ↗
• 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 12.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 8 OF 21 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479858 ↗
• 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 19 OF 20 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075332 ↗
• 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) 12.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 9 OF 20 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074789 ↗
• MalfunctionMay 25, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: THIS IS REPORT 7 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 14499863 ↗
• MalfunctionFeb 28, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6), 2022, DURING AN UNKNOWN PROCEDURE WHILE USING THE FLEXIBLE REAMERS, IT WAS NOTICED THAT A FEW OF THE REAMER HEADS WERE SIGNIFICANTLY WORN. POST OPERATIVELY, TOTAL 9 REAMER HEADS WERE IDENTIFIED AS BEING WORN. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) 12.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 6 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13621158 ↗
• 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) 12.5 MM MEDULLARY REAMER HEAD. THIS IS REPORT 9 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910513 ↗
• 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) 12.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 9 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12897205 ↗
• MalfunctionOct 20, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING FIELD INVENTORY, THERE WERE (14) REAMER HEADS THAT WERE DULL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) 12.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 9 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12667302 ↗
• MalfunctionMar 29, 2019Device Slipped; Failure to Cut; Device-Device Incompatibility; Device Slipped; Failure to Cut; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, AFTER A VISUAL INSPECTION A SYNREAM FLEXIBLE SHAFT TIP WAS NOTICED TO BE WORN AND DAMAGED. THE SYNREAM FLEXIBLE SHAFT WAS TRIED ON DIFFERENT REAMING HEADS AND WAS CONNECTED LOOSELY ON THE SHAFT. THE 12.5MM SYNREAM MEDULLARY REAMER HEAD FIT LOOSELY ON THE ASSEMBLY AND DULL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 12.5MM MEDULLARY REAMER HEAD THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8465865 ↗
• MalfunctionJan 12, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE HOSPITAL THAT THE REAMER HEAD CUTTING INSTRUMENTS ARE NOT SHARP ENOUGH. THE REAMERS ARE GETTING STUCK AND NOT COMPLETING THE ¿REAM¿ BECAUSE THEY ARE TOO DULL. THE AGE OF EACH OF THE DEVICES IS UNKNOWN. NO SPECIFIC CASE INFORMATION. THE REAMERS ARE USED REPEATEDLY FOR PROCEDURES NOT INVOLVING TRAUMA CASES. THE HOSPITAL USUALLY HAVE AT LEAST EIGHT (8) REAMER SETS IN USE AND THE MOST COMMON SIZES ARE 8.5MM THRU 12.5MM. THE HOSPITAL CENTRAL STERILE PERSONNEL INVESTIGATES THE REAMERS FOR TISSUE AND DEBRIS BEFORE EACH PROCEDURE. THIS REPORT IS FOR NINE (9) DEVICES. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7188011 ↗
• MalfunctionJan 12, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE HOSPITAL THAT THE REAMER HEAD CUTTING INSTRUMENTS ARE NOT SHARP ENOUGH. HOSPITAL FEELS THAT THIS IS A MAJOR PATIENT SAFETY ISSUE. THE REAMERS ARE GETTING STUCK AND NOT COMPLETING THE REAM BECAUSE THEY ARE TOO DULL. THE AGE OF EACH OF THE DEVICES IS UNKNOWN. NO SPECIFIC CASE INFORMATION. THE REAMERS ARE USED DAY IN AND DAY OUT FOR PROCEDURES NOT INVOLVING TRAUMA CASES. IT IS BELIEVED THAT THE HOSPITAL HAS EIGHT (8) REAMER SETS IN USE AND THE MOST COMMON SIZES USED ARE 8.5MM THRU 12.5MM. THE HOSPITAL (B)(6) PERSONNEL INVESTIGATES THE REAMERS FOR TISSUE AND DEBRIS BEFORE EACH PROCEDURE. THIS REPORT IS FOR ONE (1) 12.5MM MEDULLARY REAMER HEAD. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7187761 ↗
• MalfunctionJan 12, 2018Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  IT WAS REPORTED BY THE HOSPITAL THAT THE REAMER HEAD CUTTING INSTRUMENTS ARE NOT SHARP ENOUGH. THE REAMERS ARE GETTING STUCK AND NOT COMPLETING THE REAM BECAUSE THEY ARE TOO DULL. THE AGE OF EACH OF THE DEVICES IS UNKNOWN AND THERE IS NO SPECIFIC CASE INFORMATION. THE REAMERS ARE USED DAILY FOR PROCEDURES NOT INVOLVING TRAUMA CASES. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7187420 ↗