NA 352.130Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886982194268), received between Feb 7, 2019 and Sep 4, 2026 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (16 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 23 most recent of 23 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 50615686 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614525 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613773 ↗
• MalfunctionSep 2, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569197 ↗
• 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 23075916 ↗
• 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 Ø13.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238644 ↗
• 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 Ø13.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237373 ↗
• MalfunctionNov 30, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT CLINICAL RESOURCE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS ARE DULL. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 13.0MM MEDULLARY REAMER HEAD THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINTS (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242216 ↗
• MalfunctionNov 30, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT CLINICAL RESOURCE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS ARE DULL. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 13.0MM MEDULLARY REAMER HEAD THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242208 ↗
• MalfunctionNov 30, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT CLINICAL RESOURCE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS ARE DULL. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 13.0MM MEDULLARY REAMER HEAD THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241438 ↗
• MalfunctionNov 30, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT CLINICAL RESOURCE NURSE INDICATED THAT SEVERAL SURGEONS HAD COMPLAINED THAT THE REAMER HEADS FROM THE FLEXIBLE REAMER TRAYS ARE DULL. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 13.0MM MEDULLARY REAMER HEAD THIS IS REPORT 8 OF 10 FOR COMPLAINT PC-(B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINTS PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239791 ↗
• 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 13.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 9 OF 21 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479864 ↗
• MalfunctionJul 21, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED ON (B)(6) 2022, THE REAMER HEADS WERE DULL. THEY DO NOT CUT THROUGH BONE EFFICIENTLY ANYMORE. SURGERY WAS DELAYED 5 MINUTES DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 13.0MM MEDULLARY REAMER HEAD THIS IS REPORT 20 OF 20 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075376 ↗
• MalfunctionJul 21, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED ON (B)(6) 2022, THE REAMER HEADS WERE DULL. THEY DO NOT CUT THROUGH BONE EFFICIENTLY ANYMORE. SURGERY WAS DELAYED 5 MINUTES DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 13.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 10 OF 20 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074831 ↗
• MalfunctionFeb 28, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6), 2022, DURING AN UNKNOWN PROCEDURE WHILE USING THE FLEXIBLE REAMERS, IT WAS NOTICED THAT A FEW OF THE REAMER HEADS WERE SIGNIFICANTLY WORN. POST OPERATIVELY, TOTAL 9 REAMER HEADS WERE IDENTIFIED AS BEING WORN. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) 13.0MM MEDULLARY REAMER HEAD THIS IS REPORT 8 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13621175 ↗
• InjuryDec 10, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6), WHILE PERFORMING REAMING FOR TFNA, AND USING THE 13.0MM MEDULLARY REAMER HEAD, THE REAMING HEAD BROKE INSIDE OF THE PATIENT'S FEMUR INTO THREE PIECES. TWO WERE ABLE TO BE REMOVED, AND ONE STAYED INSIDE THE PATIENT DUE TO IT BEING INSIDE THE BONE, AND NOT IN A CONVENIENT LOCATION FOR REMOVAL. REAMING WAS STOPPED, AND TWO FRAGMENTS WERE RETRIEVED. REAMING WAS THEN RE-STARTED WITH A SMALLER REAMER HEAD, AND PROGRESSED TO A 13.5 REAMER HEAD. ADDITIONAL INSTRUMENTS WERE NEEDED FOR REMOVAL, AND ONE FRAGMENT STAYED WITH THE PATIENT. FRAGMENTS GENERATED. THERE WERE 10 MINUTES SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 13.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12977675 ↗
• 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) 13.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 10 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12667279 ↗
• MalfunctionOct 20, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING FIELD INVENTORY, THERE WERE (14) REAMER HEADS THAT WERE DULL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) 13.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 11 OF 14 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665406 ↗
• InjuryApr 26, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THE (2) FLEXIBLE SHAFT AND MEDULLARY REAMER HEAD, PRONG ON THE END WAS NOT FUNCTIONING CORRECTLY. MEDULLARY REAMER HEAD CAME OFF THE SHAFT AND WAS LEFT IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR 1 13.0MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11726842 ↗
• InjuryAug 3, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE SURGERY FOR FEMORAL TROCHANTERIC FRACTURES BY USING THE TFNA IMPLANTS. DURING THE SURGERY, THE SURGEON, THE SURGEON TRIED TO PASS THE FLEXIBLE SHAFT-CONNECTED REAMER HEAD THROUGH 2.5MM REAMER ROD WITH EXTENSION OF 900MM, BUT HE WAS UNSUCCESSFUL. WHILE CHECKING THE REAMER, HE INSERTED THE FLEXIBLE SHAFT-CONNECTED REAMER HEAD WITHOUT THE 2.5MM REAMER ROD WITH EXTENSION OF 900MM. AS A RESULT, THE REAMER HEAD CAME OFF THE FLEXIBLE SHAFT, BECAUSE THE CONNECTION BETWEEN THE FLEXIBLE SHAFT AND THE REAMER HEAD WAS DISCONNECTED IN THE INTRATHECAL SPACE. HE ATTEMPTED TO RECONNECT THE FLEXIBLE SHAFT, OR REMOVE THE REAMER HEAD WITH A GUIDE ROD BY HOOKING IT, OR PUSH UP THE UPPER CONDYLE WITH A K-WIRE, BUT HE FAILED. THE SURGEON INSERTED THE NAIL WHILE THE REAMER HEAD WAS LEFT IN THE PATIENT¿S BODY. THE SURGEON WAS COMPLETED WITH A LESS THAN 30 MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN FLEXIBLE SHAFT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1); UNKNOWN REAMING ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1); UNKNOWN K-

  Patient problems: Failure of Implant; Foreign Body In Patient; No Code Available

  MAUDE report 10360263 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, A MEDULLARY REAMER HEAD WAS FOUND TO BE BROKEN. THERE WAS NO SURGICAL PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR A 13.0 MM MEDULLARY REAMER HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9075695 ↗
• 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) 13.0MM MEDULLARY REAMER HEAD. THIS REPORT IS 6 OF 7 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8391919 ↗
• InjuryFeb 7, 2019Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS FURTHER REPORTED THAT THE PITUITARY INSTRUMENT WAS USED TO RECOVER THE REMAINS OF THE REAMER HEAD FRAGMENTS AND ADDITIONAL X-RAYS HAVE BEEN TAKEN TO VISUALIZE THE FRAGMENT THAT RELATED TO THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8317748 ↗