NA 352.120Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10886982194244), received between Jan 12, 2018 and Sep 4, 2026 — classified as 3 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (32 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 50616108 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615610 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614450 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613655 ↗
• MalfunctionSep 2, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569112 ↗
• 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 23681858 ↗
• MalfunctionMay 7, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY AT THE TIME OF MILLING WITH THE HEAD OF MILLING SYNREAM, THE SYNREAM BROKE. A PROMPT SOLUTION IS GIVEN REMOVING THE FRAGMENTS OF THIS AND PASSING TO THE DOCTOR. A NEW SYNREAM HEAD WAS USED FOR MILLING, THUS ACHIEVING SUCCESSFUL COMPLETION OF THE SURGERY, WITHOUT DISCOMFORT OF THE SPECIALIST, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976952 ↗
• 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 21927087 ↗
• 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 20267006 ↗
• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238499 ↗
• 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237360 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 WHILE IMPLANTING A FEMORAL RECON NAIL A SYNTHES FLEXIBLE12 REAMER BROKE INSIDE THE CANAL. A 12MM REAMING ROD BROKE INTO TWO PIECES INSIDE PATIENT AND BROKEN PIECES WERE RETRIEVED. THE PIECES WENT INSIDE THE CANAL AND THAT CAUSED REAMER TO CRACK. THERE WAS A TWENTY (20) MINUTES OF SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 12.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19167383 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE THE SYNREAM SHAFT BROKE AND THE DRILL HEAD REMAINED IN THE MEDULLARY CANAL. THE PATIENT HAS HISTOLOGICALLY CONFIRMED BREAST CANCER WITH MULTIPLE OSSEOUS METASTASES. THE RIGHT FEMUR WAS MARKEDLY OSTEOLYTIC WITH A CONSIDERABLE RISK OF FRACTURE. ON THE OPPOSITE SIDE ON THE LEFT MULTIPLE METASTASES WITH RISK OF FRACTURE. HOWEVER, THE BONE SUBSTANCE WAS STILL SUFFICIENT HERE, SO THERE WAS INDICATION FOR NAILLESS OSTEOSYNTHESIS. ENTRY INTO THE OPERATING ROOM, LATERAL POSITION, SURGICAL DISINFECTION AND STERILE DISINFECTION OF THE OPERATING FIELD. STARTED WITH THE LEFT SIDE FOR NAIL IMPLANTATION. PRESENTATION WAS UNDER VISUALIZATION CONTROL. OPENING OF THE MEDULLARY CANAL, INSERTION OF AN INTRAMEDULLARY WIRE WAS PERFORMED. CONTROL IN 2 PLANES. THEN REAMING OF THE MEDULLARY CANAL WAS CONDUCTED. DURING REAMING AT 12 MM, THE SYNREAM SHAFT BROKE OFF AND THE DRILL HEAD REMAINED IN THE MEDULLARY CANAL. ACCORDINGLY, THE MEDULLARY CANAL NEEDED TO BE OPENED THROUGH THE KNEE AND THE REAMER RETRIEVED, AS IT COULD NO LONGER BE PULLED OUT USING THE WIRE. THE SURGICAL TEAM HAD TO

  Patient problems: Insufficient Information

  MAUDE report 18987337 ↗
• 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 12.0MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237557 ↗
• 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 12.0MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4) AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237555 ↗
• 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 12.0MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4) AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237551 ↗
• MalfunctionNov 30, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 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 12.0MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237549 ↗
• 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) 12.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 8 OF 10 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209173 ↗
• 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) 12.0MM MEDULLARY REAMER HEAD. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209165 ↗
• MalfunctionOct 24, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN IRELAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 THE REAMER BROKE AND BECAME LODGED IN THE PATIENT'S FEMORAL CANAL. THIS WAS NOTED AND DETECTED AT THE TIME AND FOLLOWING FURTHER INTERVENTION, THE BROKEN REAMER WAS SUCCESSFULLY REMOVED INTACT AND CORTICAL FRAGMENT REPLACED AND HELD WITH A CABLE. THIS REPORT INVOLVES ONE (1) 12.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17994666 ↗
• MalfunctionApr 24, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE ITEMS SNAPPED AND SHATTERED WHILE REAMING. NOTHING WAS RETAINED IN THE PATIENT. THERE WAS A DELAY OF AROUND 15 MINUTES WHILE THE ITEMS WERE REMOVED AND A NEW SET WAS SOURCED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE 12.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794478 ↗
• 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 12.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 7 OF 21 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479587 ↗
• 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) 12.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 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 15457551 ↗
• 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) 12.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 8 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 15457418 ↗
• 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 12.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331048 ↗