NA 352.100Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10886982194206), received between Jan 11, 2018 and Sep 4, 2026 — classified as 4 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (33 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 50615873 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614064 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613353 ↗
• MalfunctionSep 2, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568540 ↗
• 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 23681849 ↗
• MalfunctionSep 4, 2025Break; Break

  IT WAS REPORTED THAT THE SIZE 10MM REAMER BROKE INSIDE THE FEMUR WHILE REAMING. ALL THE BROKEN FRAGMENTS WERE RETRIEVED. THERE WAS A 20 MINUTES OF SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT BONE IS REPORTED AS HARD AND PATIENT OUTCOME IS REPORTED AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964822 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT THE SYNREAM REAMER HEADS WERE NOTICED WORN/BROKEN DURING PROCEDURE. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277201 ↗
• InjurySep 20, 2024Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE SURGEON HAS NO INTENTION OF PERFORMING ANY REVISION PROCEDURE. NO MORE LIKELY THAN ANY OTHER PROCEDURE IN TERMS OF THE TOTAL HIP COMPONENTS IMPLANTED. THE MEDULLARY DRILL HEADS ARE CONTAINED WITHIN THE INTRAMEDULLARY CANAL SO ARE NOT A SOURCE OF SOFT TISSUE IRRITATION. THEY WERE STERILE COMPONENTS. THUS, IT WILL HAVE NO IMPACT ON THE RECOVERY AND PROGRESS POST-OPERATIVELY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20266734 ↗
• 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 Ø10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238330 ↗
• 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 Ø10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237173 ↗
• MalfunctionDec 21, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A TOTAL HIP REVISION, THE HEAD OF THE REAMER IN QUESTION BROKE OFF. THE HEAD WAS RETAINED WITHIN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 10.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18372038 ↗
• 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) 10.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 4 OF 10 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209204 ↗
• MalfunctionNov 24, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE CLINICAL RESOURCE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS WERE DULL. REPLACEMENTS ARE REQUIRED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THERE WERE NO CONSEQUENCES FOR THE PATIENT AS THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1)SYSYNREAM REAMER HEAD Ø10. THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18206836 ↗
• MalfunctionNov 24, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE CLINICAL RESOURCE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS WERE DULL. REPLACEMENTS ARE REQUIRED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THERE WERE NO CONSEQUENCES FOR THE PATIENT AS THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1)SYSYNREAM REAMER HEAD Ø10 THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18206823 ↗
• MalfunctionNov 24, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE CLINICAL RESOURCE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS WERE DULL. REPLACEMENTS ARE REQUIRED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THERE WERE NO CONSEQUENCES FOR THE PATIENT AS THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYSYNREAM REAMER HEAD 10. THIS IS REPORT 8 OF 10 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18206807 ↗
• MalfunctionNov 24, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE CLINICAL RESOURCE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS WERE DULL. REPLACEMENTS ARE REQUIRED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THERE WERE NO CONSEQUENCES FOR THE PATIENT AS THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1)SYNREAM REAMER HEAD Ø10. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18206718 ↗
• 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 10.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 4 OF 6 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149843 ↗
• 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 10.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 4 OF 21 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479581 ↗
• 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 10.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 3 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620654 ↗
• 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. THIS REPORT IS FOR A 10.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 12 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620509 ↗
• 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 4 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 15457081 ↗
• 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 10.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15450416 ↗
• 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 10.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 4 OF 8 FOR (B)(4). .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15330212 ↗
• 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 10.0MM MEDULLARY REAMER HEAD THIS IS REPORT 16 OF 20 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075189 ↗
• 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) 10.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 4 OF 20 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074573 ↗