NA 03.614.021Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034714929), received between Dec 30, 2021 and Nov 2, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SINGAPORE AS FOLLOWS: IT WAS REPORTED THAT THE HANDHELD CUTTER BROKE WHILE CUTTING THE 4.0COCR ROD. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) CUTT-PLIERS F/R. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055264 ↗
• MalfunctionSep 21, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A ROUTINE POSTERIOR CERVICAL FUSION (OCCIPUT TO C2) ON (B)(6) 2023, THE TIP OF THE SYNAPSE ROD CUTTER CHIPPED WHILE THE SURGEON WAS CUTTING A 3.5MM DIAMETER SYMPHONY COBALT CHROME ROD. DURING THE SAME SURGERY THE TIP OF THE SYMPHONY FINAL TIGHTENER SHAFT STRIPPED WHILE THE SURGEON FINAL TIGHTENING A SYMPHONY SET SCREW. A SECOND FINAL TIGHTENER SHAFT WAS USED IN ITS PLACE FOR THE REMAINDER OF THE SURGERY. THE SET SCREW DID NOT NEED TO BE REPLACED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789382 ↗
• MalfunctionApr 10, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS RECEIVED AS A BLIND UNIT FROM COLOMBIA ON JANUARY 19TH, 2023. THERE WAS NO ALLEGATION REPORTED AGAINST THE DEVICE. UPON PRODUCT INVESTIGATION PERFORMED ON MARCH 28, 2023, IT WAS NOTED THAT THERE WERE SIGNS OF CORROSION ALONG THE SURFACE OF THE DEVICE, AND THE CUTTING EDGES OF THE JAWS APPEARED TO BE DULL AND SOFTENED. THE WELD POINTS AT THE PIN SCREWS WERE BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707580 ↗
• MalfunctionMay 4, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE SURGEON WENT TO CUT A ROD AND NOTED THAT THE ROD CUTTER WAS DAMAGED AND DIFFICULT TO USE. A SECOND ROD CUTTER WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE HAD DEFORMED CUTTING SURFACES. ADDITIONALLY, TWO OF THE WELDS HOLDING THE SCREWS IN PLACE WERE OBSERVED TO BE BROKEN. THE DEVICE WAS DIFFICULT TO OPEN AND CLOSE, LIKELY DUE TO THE SCREWS BECOMING MISALIGNED AFTER THE WELDS BROKE. 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 14278269 ↗
• MalfunctionJan 31, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, DURING THE SURGERY THE BLADE BROKE. THERE WAS NO IMPACT TO THE SURGERY. THE SURGERY WAS COMPLETED WITH ANOTHER AVAILABLE INSTRUMENT. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT IMPACT. THIS REPORT INVOLVES ONE (1) ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392689 ↗
• MalfunctionDec 30, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN SPINAL PROCEDURE, THE TIP OF THE ROD CUTTER BROKE DURING USE. THE CUTTING WAS PERFORMED ON A SIDE TABLE SO NO FRAGMENTS WENT INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER UNKNOWN ROD CUTTER. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE OUTCOME AND SURGICAL DELAY ARE UNKNOWN. THIS REPORT IS FOR (1) ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118457 ↗