NA 352.110Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10886982194220), received between Jan 11, 2018 and Sep 4, 2026 — classified as 3 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (34 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 51 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 50616013 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615512 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614349 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613542 ↗
• MalfunctionSep 2, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568908 ↗
• 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 24505483 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT SYNREAM FLEXSHAFT AND 11.0MM MEDULLARY REAMER HEAD BROKE INTO MULTIPLE PIECES DURING A TFNA PROCEDURE. THE EVENT WAS IDENTIFIED INTRA-OPERATIVELY, AND THE COMPLAINT WAS SUBMITTED BY A RESOURCE NURSE. AT THIS STAGE, THERE IS INSUFFICIENT INFORMATION REGARDING PATIENT IMPACT, SURGICAL DELAY, OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 24376540 ↗
• 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 23681850 ↗
• 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 21927100 ↗
• 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 21277200 ↗
• InjurySep 20, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A TOTAL HIP REPLACEMENT PROCEDURE THE FLEXIBLE SYNREAM REAMER SYSTEM WAS USED. THE SCRUB NURSE WAS UNFAMILIAR WITH JOINT REPLACEMENT, SO WAS CO-SCRUBBED WITH AN EXPERIENCED NURSE. THE SURGEON DECIDED HE NEEDED TO DISTALLY TEAM TO ALLOW FOR CORRECT SIZING AND ADEQUATE BROACHING FOR THE CORAIL STEM. A FLEXIBLE REAMER SYSTEM WAS OPENED BY THE NURSING STAFF. IT WAS A DEPUY SYNTHES SYNREAM SYSTEM WHICH I HAD NOT SEEN PREVIOUSLY (TRAUMA DIVISION SYSTEM). THE SURGEON REQUESTED THE 10, 11 AND 12MM DRILL OPTIONS. THE EXPERIENCED SCRUB NURSE ASKED THE SURGEON IF HE WANTED TO USE THE GUIDE WIRE FROM THIS SYSTEM. THE SURGEON REPLIED THAT HE DID NOT NEED THE GUIDE WIRE, AND PROCEEDED TO DISTALLY REAM. IT WAS AFTER REAMING WITH THE 10, 11 AND 12 REAMERS THAT THE SURGEON REALIZED EACH OF THE CUTTING HEADS HAD COME OFF AND REMAINED IN THE FEMORAL I/M CANAL. THE SURGEON PROCEEDED TO PREP FEMUR AND ACETABULUM. IMPLANTED PINNACLE CUP AND LINER. THE SURGEON THEN WENT ABOUT TRYING TO REMOVE THE EMBEDDED DRILL HEADS FROM THE CANAL. THE SURGEON USED LAPAROSCOPIC GRABBERS WITHOUT SUCCESS. AN ADDITIONAL SURGEON WAS CONSULTED AND X-RAY WAS SUGGESTED. THEY USED K-W

  Patient problems: Foreign Body In Patient

  MAUDE report 20266991 ↗
• 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 Ø11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238352 ↗
• 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 Ø11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237219 ↗
• 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 11.0MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237571 ↗
• 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 11.0MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4) AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237568 ↗
• 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) 11.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 6 OF 10 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209201 ↗
• 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 Ø11. THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18206770 ↗
• 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 Ø11. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18206685 ↗
• 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 AN 11.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149822 ↗
• MalfunctionNov 1, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED (B)(6) 2023, THAT A DRILL BIT 4.2 BROKE DURING DRILLING. THE REAMER HEAD BROKE WHILE REAMING THE CHANNEL. A FRAGMENT WAS LEFT UNRETRIEVED. THIS REPORT IS FOR ONE (1) SYNREAM REAMER HEAD Ø11. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18050540 ↗
• MalfunctionMay 4, 2023Break; Crack; Break; Crack

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON APRIL 19, 2023, THAT THE DEVICE GOT BROKEN/CRACKED. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) SYNREAM REAMER HEAD Ø11. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16870092 ↗
• InjuryApr 27, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, A REAMER HEAD SIZE 11 BROKE WHILE REAMING. WHEN THE REAMER HEAD WAS PULLED OUT, PART OF IT REMAINED IN THE PATIENT. THIS REPORT IS FOR A 11.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16822988 ↗
• 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 AN 11.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 6 OF 21 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479584 ↗
• 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 11.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 5 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15619744 ↗
• 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 11.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 14 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15618868 ↗