SYMPHONY 2020-00-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705034530536), received between May 31, 2021 and Sep 8, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675190 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THE ROD CUTTER JAWS SNAPPED WHILST CUTTING A SYMPHONY 4.0 TI ROD. NO PATIENT IMPACT. PROCEDURE COMPLETED SUCCESSFULLY WITH A 5 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209505 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT USER WANTED TO ASK ABOUT GETTING A REPLACEMENT ROD CUTTER FOR THE ONE THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24936043 ↗
• MalfunctionApr 14, 2026Break

  WHILE PERFORMING A POSTERIOR CERVICAL CASE, THE SURGEON AND SCRUB TECH WERE IN THE PROCESS OF CUTTING A ROD TO FIT INTO THE POLY SCREWS. THE SCRUB TECH WAS HOLDING BOTH ENDS OF THE ROD WITH A KOCHER AND ROD HOLDER WHEN USING THE SYMPHONY ROD HOLDER TO MAKE THE CUT ON THE ROD AND IT BROKE WITH A PIECE COMING OFF OF THE INSTRUMENT HITTING THE SCRUB TECH¿S FINGER CAUSING A SMALL CUT BY THEIR FINGER NAIL. THE SURGEON CONTINUED WITH THE CASE WHILE THE SCRUB TECH WENT DOWN TO THE ER TO HAVE HER FINGER EXAMINED. THIS DID NOT AFFECT THE PATIENT IN SURGERY AT THE TIME AND ONLY ADDED TWO TO THREE MINUTES TO THE CASE. AT THE ER, THEY CLEANED THE SCRUB TECH¿S WOUND AND BANDAGED IT WITHOUT NEEDING ANY STITCHES. THEY ALSO TOOK A SAMPLE OF BLOOD TO CHECK FOR ANY INFECTIOUS DISEASES. THE SCRUB TECH RETURNED TO THE OR WITHOUT ANY INCIDENCES. THERE HAS NOT BEEN ANY ISSUE WITH THEIR FINGER SINCE THEN THAT HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24872797 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT THIS WAS POSTERIOR CERVICAL FUSION SURGERY PERFORMED ON (B)(6) 2026. DURING THE SURGERY, PART OF THE HINGE ON THE CUTTER WAS BROKEN WHEN THE SURGEON WAS PERFORMING ROD CUT (THE PART DID NOT AFFECT THE USE OF THE PRODUCT). THE PRODUCT IN QUESTION WAS NOT A PROBLEM TO USE AND ABLE TO CUT AS USUAL, SO THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744341 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE SYMPHONY ROD CUTTER PART BROKE USING THE OPEN END TO CUT THE ROD IN SITU. NO HARM WAS DONE TO THE PATIENT; NO DELAY WAS CAUSED. THE PIECE THAT BROKE WAS RECOVERED. STAFF HAD ANOTHER CUTTER OPEN AND USED IT TO CUT THE ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210555 ↗
• MalfunctionJun 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A POSTERIOR FIXATION WITH THE SYMPHONY SYSTEM, THE TIP OF THE CUTTING TOOL BROKE WHEN IT WAS NECESSARY TO CUT A 4.0 MM TITANIUM ROD, RENDERING THE INSTRUMENT USELESS. A SECOND CUTTER WAS USED TO CUT THE ROD SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185085 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 WHEN GOING TO CUT THE COCR ROD, A PIECE OF THE ROD CUTTER BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME. THERE WAS GENERATION OF FRAGMENTS WHICH WERE REMOVED BY ADDITIONAL INTERVENTION. THIS REPORT IS FOR ONE (1) ROD CUTTER 3.5 AND 4.0 RODS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067950 ↗
• MalfunctionDec 1, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE INSTRUMENT WAS BROKEN DURING BAR CUTTING. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM. THIS REPORT IS FOR ONE (1) ROD CUTTER 3.5 AND 4.0 RODS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248688 ↗
• MalfunctionNov 3, 2023Break; Break

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023 THE SYMPHONY ROD CUTTER IN QUESTION WAS BROKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE OF THE SAME TYPE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM ROD CUTTER FOR 3.5MM AND 4.0MM RODS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067741 ↗
• MalfunctionMay 17, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE SYMPHONY ROD CUTTER TIP BROKE OFF UNDER NORMAL USAGE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM ROD CUTTER FOR 3.5MM AND 4.0MM RODS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945493 ↗
• MalfunctionMay 15, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS ON AN UNKNOWN DATE IN APRIL 2023, PART OF THE CUTTING TOOL FOR CUTTING RODS WAS BROKEN. IT IS NOT POSSIBLE TO CUT A ROD WITH IT. THIS WAS DETECTED IN THE STERILE PROCESSING DEPARTMENT; NO PATIENT OR SURGERY INVOLVED. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM ROD CUTTER FOR 3.5MM AND 4.0MM RODS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929865 ↗
• MalfunctionFeb 15, 2023Break; Material Deformation; Break; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING INSPECTION FROM MDRD, THE SYMPHONY ROD CUTTER WAS BEND AND BROKEN. THE INSTRUMENT WAS REMOVED FROM THE SET. MDRD IS UNABLE TO LOCATE THE BENDER. THERE WERE NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) ROD CUTTER 3.5 AND 4.0 RODS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380513 ↗
• MalfunctionFeb 8, 2023Break; Break

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE SYMPHONY BAR CUTTER PLIERS BROKE OFF. THERE WAS NO REPORTED PATIENT HARM. THE SURGERY WAS DELAYED FOR APPROXIMATELY 5 MINUTES, BUT WAS COMPLETED SUCCESSFULLY. FRAGMENTS GENERATED WERE REMOVED WITH NO ADDITIONAL INTERVENTION REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM ROD CUTTER FOR 3.5MM AND 4.0MM RODS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330028 ↗
• MalfunctionNov 3, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SOUTH KOREA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING POSTERIOR CERVICAL FUSION USING SYMPHONY SYSTEM, THE SURGEON TRIED TO CUT THE ROD BUT THE ROD CUTTER WAS BROKEN. ANOTHER ROD CUTTER WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) SYMPHONY OCT SYSTEM ROD CUTTER FOR 3.5MM AND 4.0MM RODS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721903 ↗
• MalfunctionJul 21, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, WHEN SHORTENING A COCR ROD DIA 4.0 THE CUTTING EDGES FRACTURED. ANOTHER CUTTING INSTRUMENT WAS AVAILABLE AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) SYMPHONY OCT SYSTEM ROD CUTTER FOR 3.5MM AND 4.0MM RODS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075562 ↗
• MalfunctionJun 2, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED WHILE CUTTING THE TITANIUM ROD, THE ROD CUTTER BROKE. IT WAS NOTED FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT. THIS REPORT IS FOR A ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14578230 ↗
• MalfunctionDec 31, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE A CRACK IN THE TIP OF THE ROD CUTTER WAS NOTICED. THE ISSUE WAS FOUND AFTER IT WAS USED TO CUT A ROD. THERE WERE NO FRAGMENTS GENERATED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SYMPHONY OCT SYSTEM ROD CUTTER FOR 3.5MM AND 4.0MM RODS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13129386 ↗
• MalfunctionNov 23, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE ROD CUTTER IS BROKE. IT WAS UNKNOWN HOW DAMAGED HAPPENED. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SYMPHONY ROD 4.0MM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) ROD CUTTER 3.5 AND 4.0 RODS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861089 ↗
• MalfunctionMay 31, 2021Material Discolored; Material Discolored

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE INSTRUMENT WAS DISCOLORED AFTER STERILIZATION. THERE WAS NO SURGERY AND PATIENT IMPACTS ARE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) ROD CUTTER 3.5 AND 4.0 RODS. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907327 ↗