NA 352.140Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982194282), received between Mar 5, 2019 and Sep 20, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 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 Ø13.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20265859 ↗
• 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 STREAM REAMER HEAD Ø14.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237630 ↗
• MalfunctionNov 27, 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, SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS WERE DULL. THERE WERE NO SURGICAL DELAYS OR PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 14.0MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208776 ↗
• MalfunctionNov 27, 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, SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS WERE DULL. THERE WERE NO SURGICAL DELAYS OR PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 14.0MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208769 ↗
• MalfunctionNov 27, 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, SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS WERE DULL. THERE WERE NO SURGICAL DELAYS OR PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 14.0MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208768 ↗
• MalfunctionNov 27, 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, SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS WERE DULL. THERE WERE NO SURGICAL DELAYS OR PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 14.0MM MEDULLARY REAMER HEAD. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208766 ↗
• 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 14.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 11 OF 21 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479866 ↗
• MalfunctionOct 20, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING FIELD INVENTORY, THERE WERE (14) FOURTEEN REAMER HEADS THAT WERE DULL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 14.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 13 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665580 ↗
• MalfunctionJul 30, 2019Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF INSTRUMENTS WHILE PUTTING THE SET BACK TOGETHER, THE TWO (2) MEDULLARY REAMER HEAD WERE NOTICED DULL TO THE TOUCH AND APPEARANCE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 14.0 MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8841938 ↗
• InjuryJul 1, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE REAMER HEAD BROKE OFF AND PART OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1)14.0 MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8749295 ↗
• MalfunctionMar 5, 2019Dull, Blunt; Naturally Worn; Dull, Blunt; Naturally Worn

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE INSPECTING THE FLEXIBLE REAMER SET AFTER IT HAD GONE THROUGH A DECONTAMINATION PROCESS. IT WAS DISCOVERED THAT THERE WERE SEVEN (7) REAMERS NAMELY: THE 8.5MM MEDULLARY REAMER HEAD, 9.5MM MEDULLARY REAMER HEAD, 11.0MM MEDULLARY REAMER HEAD, 11.5MM MEDULLARY REAMER HEAD, 12.0MM MEDULLARY REAMER HEAD, 13.0MM MEDULLARY REAMER HEAD, AND 14.0MM MEDULLARY REAMER HEAD WERE WORN OR APPEARED TO BE DULL. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR ONE (1) 14.0MM MEDULLARY REAMER HEAD. THIS REPORT IS 7 OF 7 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8391930 ↗