NA 352.105Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10886982194213), received between Jan 11, 2018 and Sep 4, 2026 — classified as 7 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (47 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 67 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 50615997 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615451 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614262 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613511 ↗
• MalfunctionSep 2, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568851 ↗
• MalfunctionMar 4, 2026Failure to Cut

  IT WAS REPORTED ON (B)(6) 2026, THAT UPON INSPECTION OF A NEW FLEXIBLE REAMER PAN, 3 REAMERS WERE FOUND TO BE DULL, AND THE COUPLING MECHANISM WAS MALFUNCTIONING (POPS OFF REAMER SHAFT). THIS WAS BEFORE ANY CASES WERE PERFORMED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505447 ↗
• 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 21927084 ↗
• 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 21277204 ↗
• MalfunctionSep 17, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORFI WITH THE REAMER IN QUESTION FOR THE FEMORAL TROCHANTERIC FRACTURE. THE REAMER IN QUESTION WAS USED FOR THE PATIENT WITH NARROW INTRAMEDULLARY. WHEN STARTING WITH 8.5MM AND USING 10.5MM, THE REAMER DID NOT PASS THROUGH. THE GUIDE ROD WAS REMOVED AND WHEN REAMING WAS PERFORMED, IT WAS DISLODGED IN THE MEDULLA AND CAME OFF. ALTHOUGH THE SURGEON TRIED TO REMOVE IT, IT FELL SO DEEP THAT THE SURGEON GAVE UP ON REMOVING IT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE SURGEON COMMENTED THAT IT WAS WORKING FINE UNTIL HALFWAY THROUGH WHEN IT FAILED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH REGULAR FIXATION OF FRACTURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20238986 ↗
• 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 Ø10.5

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237917 ↗
• 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 Ø10.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237212 ↗
• MalfunctionApr 10, 2024Entrapment of Device; Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Entrapment of Device; 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) 10.5MM MEDULLARY REAMER HEAD THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19084081 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A REVISION TFNA PROCEDURE, THE HYBRID HANDLE WAS USED TO ATTACH THE TFNA, BUT IT WAS NOT PROPERTY CONNECTED. DURING INSERTION THE NOTCH BENT AND THE TFNA NAIL WAS WASTED. A NEW INSERTION HANDLE AND A BIGGER DIAMETER NAIL WAS USED. DURING REAMING A 10.5 REAMER HEAD WAS USED AND BROKE INTRA-OP, RIA 2 WAS THEN USED AND THEN THE 12.5 WAS USED BUT COULD NOT SNAP OFF REAMER HEAD OFF SHAFT. THERE WAS 5 MINUTES SURGERY DELAYED DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE 10.5MM MEDULLARY REAMER HEAD FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842233 ↗
• 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) 10.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 5 OF 10 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209202 ↗
• 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 (1SYNREAM REAMER HEAD Ø10.5. THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18206788 ↗
• 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 Ø10.5. THIS IS REPORT 5 OF 10 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18206738 ↗
• 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 Ø10.5. THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18206701 ↗
• 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 Ø10.5. THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18206691 ↗
• 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 10.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149823 ↗
• MalfunctionSep 12, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED THAT THE SYNREAM BIT 10. 5 BROKE DURING REAMING OF FEMUR CANAL. THERE WAS NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SYNREAM REAMER HEAD Ø10.5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731503 ↗
• MalfunctionMay 3, 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, STAFF INDICATED THAT A 10.5MM REAMER HEAD WAS DULL DUE TO SEVERAL USES AND WEAR AND TEAR OVER TIME. THERE WERE NO PATIENT ISSUES, AND THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 10.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16863261 ↗
• MalfunctionMar 6, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2023, THE SYNREAM REAMER SHAFT AND REAMER HEAD BROKE IN THE FEMORAL SHAFT DURING NORMAL USE. ALL PIECES WERE SUCCESSFULLY REMOVED AND NO ADVERSE OUTCOMES OCCURRED. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE 10.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16487719 ↗
• 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 10.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 5 OF 21 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479582 ↗
• MalfunctionOct 17, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM (B)(6) 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 10.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 4 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620368 ↗
• MalfunctionOct 17, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 25-SEPTEMBER-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 10.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 13 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15619095 ↗