NA 352.085Recalls & reported problems

Summary

The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 10886982194176), received between Mar 3, 2017 and Sep 30, 2026 — classified as 17 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (68 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 119 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50951574 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615892 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615074 ↗
• MalfunctionSep 4, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614119 ↗
• MalfunctionSep 2, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568568 ↗
• MalfunctionFeb 27, 2026Failure to Cut

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE SYNREAM 8.5 INTRAMEDULLARY REAMING HEAD FAILED TO CUT AND PREVENT REAMING IN THE PATIENT'S SPINAL CANAL. THIS CAUSED DISCOMFORT FOR THE SPECIALIST, WHO STRONGLY RECOMMENDED PREVENTIVE MAINTENANCE OF THE REAMERS BEFORE SENDING THEM TO SURGERY. THIS ALSO RESULTED IN A DELAY OF APPROXIMATELY TWO (2) HOURS IN THE SURGICAL TIME IN ORDER TO GET NEW REAMING UNIT AND REQUIRING ADDITIONAL ANESTHESIA TO COMPLETE THE PROCEDURE; HOWEVER, THE PATIENT'S CONDITION REMAINED STABLE AND WITHOUT FURTHER COMPLICATIONS DURING AND AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474704 ↗
• MalfunctionJan 12, 2026Device Slipped

  IT WAS REPORTED THAT A 8.5MM MEDULLARY REAMER HEAD WON¿T STAY ATTACHED TO REAMER SHAFT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045992 ↗
• MalfunctionDec 30, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE DRILLING OF THE TIBIAL MEDULLARY CANAL, THE DRILLING HEAD DETACHED FROM THE FLEXIBLE SHAFT AND BECAME LODGED INSIDE THE TIBIAL MEDULLARY CANAL. FOR SEVERAL MINUTES, MULTIPLE ATTEMPTS WERE DONE TO REMOVE THE INSTRUMENT, BUT WERE UNSUCCESSFUL. THE ONLY RESULT WAS THAT THE PIECE SHIFTED FURTHER ONTO THE TIBIAL PLATEAU, MAKING EXTRACTION EVEN MORE DIFFICULT. GIVEN THIS SITUATION, THE DECISION WAS MADE TO CEASE ALL ATTEMPTS FOR EXTRACTION AND LEAVE THE DEVICE EMBEDDED WITHIN THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23928520 ↗
• MalfunctionDec 11, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING THE PROCEDURE FOR A TNA TIBIAL NAIL, TWO 8.5 MM SYNREAM SYSTEM STARTER DRILLS FRACTURED DURING DRILLING, LEAVING FRAGMENTS LODGED IN THE INTRAMEDULLARY CANAL. THIS PROCEDURE WAS PERFORMED WITH THE OLIVE-SHAPED GUIDE WIRE AS REQUIRED. THE SITUATION WAS DETECTED AND IMMEDIATELY REPORTED BY THE OPERATING ROOM NURSE, WHO RECORDED THE EVENT AS AN INCIDENT ACCORDING TO THE ESTABLISHED PROTOCOL. THE HOSPITAL'S TECNOVIGILANCE DEPARTMENT WAS ALSO PROMPTLY INFORMED AND PROCEEDED TO REMOVE BOTH DRILLS, WHICH REMAIN IN THEIR POSSESSION. IT IS IMPORTANT TO NOTE THAT IT WAS NOT POSSIBLE TO REMOVE THE REMAINING FRAGMENTS, WHICH ARE STILL IN THE INTRAMEDULLARY CANAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 23782704 ↗
• MalfunctionDec 11, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING THE PROCEDURE FOR A TNA TIBIAL NAIL, TWO 8.5 MM SYNREAM SYSTEM STARTER DRILLS FRACTURED DURING DRILLING, LEAVING FRAGMENTS LODGED IN THE INTRAMEDULLARY CANAL. THIS PROCEDURE WAS PERFORMED WITH THE OLIVE-SHAPED GUIDE WIRE AS REQUIRED. THE SITUATION WAS DETECTED AND IMMEDIATELY REPORTED BY THE OPERATING ROOM NURSE, WHO RECORDED THE EVENT AS AN INCIDENT ACCORDING TO THE ESTABLISHED PROTOCOL. THE HOSPITAL'S TECNOVIGILANCE DEPARTMENT WAS ALSO PROMPTLY INFORMED AND PROCEEDED TO REMOVE BOTH DRILLS, WHICH REMAIN IN THEIR POSSESSION. IT IS IMPORTANT TO NOTE THAT IT WAS NOT POSSIBLE TO REMOVE THE REMAINING FRAGMENTS, WHICH ARE STILL IN THE INTRAMEDULLARY CANAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 23782695 ↗
• MalfunctionDec 2, 2025Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SYNTHES FLEXIBLE REAMERS WERE USED WITHOUT A GUIDE WIRE, RESULTING IN THE 8.5MM REAMER HEAD COMING OFF AND BEING LEFT BEHIND IN THE FEMORAL CANAL. SURGEON DECIDED TO LEAVE THE REAMER HEAD IN THE FEMORAL CANAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23696243 ↗
• MalfunctionAug 13, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE PATIENT ARRIVED AT SURGERY WITH INTERTROCANTERIC FRACTURE. THE PATIENT HAD PREVIOUSLY UNDERGONE KNEE PROSTHESIS REVISION. THE SPECIALIST INITIALLY WANTED TO PLACE A SHORT TFNA NAIL. AN ENTRY POINT WAS ESTABLISHED, AND THE CANAL WAS REAMED. THE FRONT-CUTTING REAMER BROKE WHEN IT HIT THE PROSTHESIS STEM, LEAVING PART OF IT IN THE CANAL. THE SURGICAL PIN WAS CHANGED TO A DHS PIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 22796977 ↗
• 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 21927081 ↗
• MalfunctionApr 23, 2025Break; Break

  DURING THE REAMING OF THE MEDULLARY CANAL, THE FRAGMENTS SECURED WITH SHANZ SHIFTED AND THE REAMER HEAD BROKE AT THE CLAMPING END INSIDE THE CANAL. THE SALES REPRESENTATIVE ADDITIONALLY CHECKED THE FLEXIBLE SHAFT AFTERWARDS AND NOTICED THE TIP WAS SLIGHTLY BENT.

  Patient problems: Insufficient Information

  MAUDE report 21893450 ↗
• MalfunctionFeb 26, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMER HEAD IS DAMAGED AND NEEDS A WEAR AND TEAR REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 21468445 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT DURING A TIBIAL NAIL PROCEDURE ON (B)(6) 2024, AN 8.5 REAMER HEAD WOULDN'T ADVANCE. IT LOST ITS ABILITY TO CUT AND THE HOSPITALS SECOND SET HAD A HOLE IN IT SO THEY HAD TO RESORT TO MAKING A PLAN TO REAM THE MEDULLARY CANAL. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 20757481 ↗
• MalfunctionNov 18, 2024Failure to Cut; Failure to Cut

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS CONFIRMED THAT THE SECOND SET BELONGED TO DEPUY; IT WAS THEIR SECOND CONSIGNED SET.

  Patient problems: Insufficient Information

  MAUDE report 20709219 ↗
• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED, THAT DURING THE PROCEDURE ON AN UNKNOWN DATE. THE SYMREAM WAS PASSED TO THE SPECIALIST WITH THE DRILL TO START THE INTRAMEDULLARY CANAL. BUT, AT THE TIME OF PASSING, THE SYMREAM DRILL SPLIT. THEN PROCEEDED TO REMOVE ALL THE FRAGMENTS, WHICH COULD BE REMOVED IN THEIR ENTIRETY FROM THE CHANNEL AND CONTINUED WITH THE NORMAL REAMING. PASSING TO THE SPECIALIST NOW A DRILL OF 9.0. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ALTERATIONS IN THE SURGICAL TIMES. AND WITHOUT AFFECTING THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20707841 ↗
• MalfunctionOct 28, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT SYNREAM REAMER HEAD BROKE WHILE REAMING A TIBIA. THERE WAS A SLIGHT DELAY DURING THE SURGERY AND FRAGMENTS OF THE REAMER HEAD COULD NOT BE RETRIEVED FROM THE TIBIA.

  Patient problems: Foreign Body In Patient

  MAUDE report 20545086 ↗
• MalfunctionOct 18, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE 8.5 REAMER WASN'T CUTTING CORRECTLY. HAD TO OPEN A NEW SET AND USE ANOTHER 8.5 REAMER TO CONTINUE THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482932 ↗
• 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 Ø8.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237935 ↗
• 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 8.5MM MEDULLARY REAMER HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236686 ↗
• MalfunctionJun 21, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT BROKEN TIPS OF REDUCTION FORCEPS WERE DISCOVERED. THE 8.5 REAMERS X 3 NEED TO BE CHANGED AS THEY ARE NOT LONGER SHARP. IT IS UNKNOWN IF PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING OR IF THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL. THIS REPORT IS FOR ONE (1) 8.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581648 ↗
• MalfunctionJun 21, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT BROKEN TIPS OF REDUCTION FORCEPS WERE DISCOVERED. THE 8.5 REAMERS X 3 NEED TO BE CHANGED AS THEY ARE NOT LONGER SHARP. IT IS UNKNOWN IF PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING OR IF THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL. THIS REPORT IS FOR ONE (1) 8.5MM MEDULLARY REAMER HEAD THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581475 ↗
• MalfunctionJun 21, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT BROKEN TIPS OF REDUCTION FORCEPS WERE DISCOVERED. THE 8.5 REAMERS X 3 NEED TO BE CHANGED AS THEY ARE NOT LONGER SHARP. IT IS UNKNOWN IF PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING OR IF THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL. THIS REPORT IS FOR ONE (1) 8.5MM MEDULLARY REAMER HEAD THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581236 ↗