NA 352.040Recalls & reported problems

Summary

The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 10886982194114), received between Jan 15, 2014 and Aug 31, 2026 — classified as 15 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Break” (75 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 148 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519232 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THAT A SIZE 13MM REAMER HEAD AND THE REAMER SHAFT BROKE INSIDE THE PATIENT¿S CANAL WHEN REAMING FOR A LONG TFNA. A SURGICAL INSTRUMENT WAS USED TO RETRIEVE THE BROKEN FRAGMENTS. A SUBSEQUENT 12MM REAMER WAS THEN USED AND AN 11MM NAIL WAS INSERTED WITHOUT ANY FURTHER ISSUES AND THE PROCEDURE WAS COMPLETED. THE BROKEN REAMER SHAFT AND BROKEN REAMER HEAD WERE DISPOSED OF IN THE SHARPS CONTAINER. THERE WAS THE SURGICAL DELAY OF 5 MINUTES. BROKEN PIECES REMOVED FROM THE PATIENT. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075991 ↗
• MalfunctionSep 8, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025. THE TIP OF THE REAMING SHAFT WAS DAMAGED; ONE OF THE PRONGS WAS DISMANTLED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992745 ↗
• MalfunctionJul 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 2 REAMER SHAFTS WERE WORN TO THE POINT WHERE THEY DO NOT HOLD THE REAMER HEAD ON ANYMORE AND THE REAMER HEADS CAN FALL OFF DURING A CASE. THIS IS NOT FROM ANY PARTICULAR SURGERY, BUT IS WORN FROM YEARS OF USE. NO PATIENT HAS BEEN HARMED, AND ALL CASES HAVE BEEN FINISHED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631197 ↗
• MalfunctionJul 28, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE 2 REAMER SHAFTS WERE WORN TO THE POINT WHERE THEY DO NOT HOLD THE REAMER HEAD ON ANYMORE AND THE REAMER HEADS CAN FALL OFF DURING A CASE. THIS IS NOT FROM ANY PARTICULAR SURGERY, BUT IS WORN FROM YEARS OF USE. NO PATIENT HAS BEEN HARMED, AND ALL CASES HAVE BEEN FINISHED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631074 ↗
• MalfunctionJul 7, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE REAMER SHAFTS DIDN'T HOLD THE REAMER HEADS SECURELY. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THE REAMER HEADS ARE FINE; THE REAMER SHAFTS SEEM TO NOT HOLD THE REAMER HEADS AS FIRM AS THEY USED TO; THE HEADS CAN EASILY COME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413118 ↗
• MalfunctionJul 7, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE REAMER SHAFTS DIDN¿T HOLD THE REAMER HEADS SECURELY. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THE REAMER HEADS ARE FINE; THE REAMER SHAFTS SEEM TO NOT HOLD THE REAMER HEADS AS FIRM AS THEY USED TO; THE HEADS CAN EASILY COME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413084 ↗
• MalfunctionApr 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT SHAFT WAS BENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881981 ↗
• MalfunctionApr 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT SHAFT WAS BENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881977 ↗
• MalfunctionApr 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS DOING A PRODUCT DEMO FOR AN IN-SERVICE USING THE SYSTEM. UPON COMPLETION, THEY COULD NOT REMOVE THE REAMER HEAD FROM THE REAMER SHAFT. THIS DID NOT OCCUR IN SURGERY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857315 ↗
• MalfunctionNov 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TRAYS WERE FALLING APART AND HAVE BEEN DEEMED UN-USABLE IN SURGERY. THE REAMER HEADS ARE NOT STICKING TO SHAFTS ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621167 ↗
• MalfunctionNov 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TRAYS WERE FALLING APART AND HAVE BEEN DEEMED UN-USABLE IN SURGERY. THE REAMER HEADS ARE NOT STICKING TO SHAFTS ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620424 ↗
• MalfunctionNov 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TRAYS WERE FALLING APART AND HAVE BEEN DEEMED UN-USABLE IN SURGERY. THE REAMER HEADS ARE NOT STICKING TO SHAFTS ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620358 ↗
• MalfunctionNov 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TRAYS WERE FALLING APART AND HAVE BEEN DEEMED UN-USABLE IN SURGERY. THE REAMER HEADS ARE NOT STICKING TO SHAFTS ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619878 ↗
• MalfunctionNov 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TRAYS WERE FALLING APART AND HAVE BEEN DEEMED UN-USABLE IN SURGERY. THE REAMER HEADS ARE NOT STICKING TO SHAFTS ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619836 ↗
• MalfunctionNov 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON OCTOBER 7, 2024, THE TRAYS WERE FALLING APART AND HAVE BEEN DEEMED UN-USABLE IN SURGERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585889 ↗
• MalfunctionSep 3, 2024Material Deformation; Scratched Material; Material Deformation; Scratched Material

  IT WAS REPORTED THAT ON (B)(6) 2024, THE END OF 5.0MM FLEXIBLE SHAFT HAS BEEN BENT AND NO LONGER BEING USED FOR SURGERY. LOT HAS BEEN DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THIS WAS NOTICED BEFORE CASE. THIS REPORT IS FOR ONE (1) 5.0MM FLEXIBLE SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130449 ↗
• MalfunctionJun 17, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE FLEXIBLE REAMER SHAFT BROKE FROM DISENGAGING PRODUCT OFF THE ADAPTOR CONNECTOR. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. THE PATIENT DID NOT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) 5.0MM FLEXIBLE SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548449 ↗
• MalfunctionApr 10, 2024Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE, THE SURGEON WAS ATTEMPTING TO REAM THE MEDULLARY CANAL OF THE FEMUR WHEN THE 10.5MM MEDULLARY REAMER HEAD BECAME DISCONNECTED FROM THE FLEXIBLE SHAFT WITHIN THE CANAL. THE SURGEON WAS NOT USING A REAMING ROD WITH BALL TIP WHICH THE SURGICAL TECHNIQUE STATES TO NEVER DO. THE SURGEON WAS UNABLE TO RETRIEVE THE REAMER HEAD WITHIN THE CANAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 5.0MM FLEXIBLE SHAFT THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19084085 ↗
• MalfunctionJan 2, 2024Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Illegible Information; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, IT WAS NOTICED THAT SEVERAL INSTRUMENTS WERE DAMAGED. THE HANDLE WITH QUICK COUPLING, SMALL WAS WORN. THE PLASTIC ON THE HANDLE WAS CRACKED. THE DRIVE ADAPTOR QC FOR 5.0 SCHANZ SCREWS IS A QUICK CONNECT FOR SHANZ PINS. WHERE THE QUICK CONNECT GOES INTO THE DRILL, IT IS WORN AND UNABLE TO GO INTO THE DRILL. THE 5.0MM FLEXIBLE SHAFT WAS WORN. THE TIP OF THE REAMER SHAFT HAS PRONGS ON IT, AND THE PRONGS WERE BENT AND UNABLE TO HOLD THE REAMER HEAD IN PLACE. ANOTHER 5.0MM FLEXIBLE SHAFT WAS DAMAGED. THE 5.0MM FLEXIBLE SHAFT 620MM WAS WORN. IT WAS A LONG REAR SHAFT, AND THE TIP OF THE REAMERS SHAFT HAS PRONGS ON IT, AND THE PRONGS WERE BENT AND UNABLE TO HOLD THE REAMER HEAD IN PLACE. IT IS UNKNOWN WHEN THE DAMAGE OCCURRED TO THESE ITEMS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 5.0MM FLEXIBLE SHAFT. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427755 ↗
• MalfunctionJan 2, 2024Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Illegible Information; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, IT WAS NOTICED THAT SEVERAL INSTRUMENTS WERE DAMAGED. THE HANDLE WITH QUICK COUPLING, SMALL WAS WORN. THE PLASTIC ON THE HANDLE WAS CRACKED. THE DRIVE ADAPTOR QC FOR 5.0 SCHANZ SCREWS IS A QUICK CONNECT FOR SHANZ PINS. WHERE THE QUICK CONNECT GOES INTO THE DRILL, IT WAS WORN AND UNABLE TO GO INTO THE DRILL. THE 5.0MM FLEXIBLE SHAFT WAS WORN. THE TIP OF THE REAMER SHAFT HAS PRONGS ON IT, AND THE PRONGS WERE BENT AND UNABLE TO HOLD THE REAMER HEAD IN PLACE. ANOTHER 5.0MM FLEXIBLE SHAFT WAS DAMAGED. THE 5.0MM FLEXIBLE SHAFT 620MM WAS WORN. IT WAS A LONG REAR SHAFT, AND THE TIP OF THE REAMERS SHAFT HAS PRONGS ON IT, AND THE PRONGS WERE BENT AND UNABLE TO HOLD THE REAMER HEAD IN PLACE. IT IS UNKNOWN WHEN THE DAMAGE OCCURRED TO THESE ITEMS. THERE WAS NO PATIENT INVOLVEMENT. THE LOT NUMBERS ON THE DEVICES WERE WORN AND NOT LEGIBLE. THIS REPORT INVOLVES ONE 5.0MM FLEXIBLE SHAFT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427724 ↗
• MalfunctionDec 28, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN RFNA CASE, THE REAMING TOOK OFF THE NAIL AND THE REAMER SHAFT BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. THE BROKEN REAMER SHAFT WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT REAMER SHAFT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM FLEXIBLE SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18415587 ↗
• MalfunctionOct 31, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE REAMER SHAFT BROKE WHILE BEING USED. SWITCH TO ANOTHER REAMER SHAFT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 5.0MM FLEXIBLE SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038686 ↗
• 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) 5.0MM FLEXIBLE SHAFT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17379137 ↗
• MalfunctionJun 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HEAD OF THE FLEX REAMER SHAFT WAS BENT. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0MM FLEXIBLE SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17197520 ↗