NA 388.750Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705034773766), received between Dec 12, 2016 and Apr 20, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Material Integrity Problem

  IT WAS REPORTED THE HANDLE BROKE; NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927789 ↗
• MalfunctionFeb 17, 2026Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, UPON INSPECTION AFTER RETURNING THE ROD CUTTER FROM THE SHORT-TERM LOANER, THE DISTRIBUTION CENTER FOUND THAT THE ROD DIAMETER MARKINGS WERE NOT FOUND ON EACH HOLE. THIS EVENT HAS NO SURGERY INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363205 ↗
• MalfunctionMar 8, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE USS TABLE TOP ROD CUTTER/BENDER HANDLE BROKE OFF WHILE CUTTING A ROD DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT WITH THE EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TABLE TOP ROD CUTTER AND BENDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501253 ↗
• MalfunctionDec 22, 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, THE TABLE TOP ROD CUTTER AND BENDER BROKE. THERE WAS NO PATIENT OR SURGICAL IMPACT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) TABLE TOP ROD CUTTER AND BENDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13063325 ↗
• MalfunctionJun 2, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TABLE TOP ROD CUTTER AND BENDER WAS REPORTED TO BE BROKEN. THERE WAS NO SURGICAL OR PATIENT IMPACT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR 1 TABLE TOP ROD CUTTER AND BENDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921457 ↗
• MalfunctionApr 6, 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, THE PATIENT UNDERWENT FOR A SURGERY. IT WAS REPORTED ABOUT A BROKEN ROD CUTTER. IT WAS UNKNOWN HOW IT OCCURRED. IN THE REPORT THE CUSTOMER ALSO MENTIONED THREE OTHER ROD CUTTERS. THERE WAS NO SURGERY AND PATIENT IMPACTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) TABLE TOP ROD CUTTER AND BENDER. THIS REPORT IS 3 OF 4 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620220 ↗
• MalfunctionApr 6, 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, THE PATIENT UNDERWENT FOR A SURGERY. IT WAS REPORTED ABOUT A BROKEN ROD CUTTER. IT WAS UNKNOWN HOW IT OCCURRED. IN THE REPORT THE CUSTOMER ALSO MENTIONED THREE OTHER ROD CUTTERS. THERE WAS NO SURGERY AND PATIENT IMPACTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) TABLE TOP ROD CUTTER AND BENDER. THIS REPORT IS 4 OF 4 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620218 ↗
• MalfunctionApr 6, 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, THE PATIENT UNDERWENT FOR A SURGERY. IT WAS REPORTED ABOUT A BROKEN ROD CUTTER. IT WAS UNKNOWN HOW IT OCCURRED. IN THE REPORT THE CUSTOMER ALSO MENTIONED THREE OTHER ROD CUTTERS. THERE WAS NO SURGERY AND PATIENT IMPACTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) TABLE TOP ROD CUTTER AND BENDER. THIS REPORT IS 2 OF 4 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620217 ↗
• MalfunctionApr 6, 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, THE PATIENT UNDERWENT FOR A SURGERY. IT WAS REPORTED ABOUT A BROKEN ROD CUTTER. IT WAS UNKNOWN HOW IT OCCURRED. IN THE REPORT THE CUSTOMER ALSO MENTIONED THREE OTHER ROD CUTTERS. THERE WAS NO SURGERY AND PATIENT IMPACTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) TABLE TOP ROD CUTTER AND BENDER. THIS REPORT IS 1 OF 4 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620206 ↗
• MalfunctionFeb 10, 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 A POSTERIOR SPINAL FUSION FOR THE TREATMENT OF INFECTION, THE ROD HOLDER BROKE WHEN THE RODE WAS BEING CUT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: USS ROD (PART NUMBER UNKNOWN, LOT TBADJR, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TABLE TOP ROD CUTTER AND BENDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307438 ↗
• MalfunctionFeb 2, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A CASE THE ROD CUTTER HANDLE BROKE WHEN SIZING ROD FOR PATIENT. THE ACCOUNT HAD ANOTHER ROD CUTTER THAT WAS USED TO SIZE THE ROD. SURGERY WAS NOT DELAYED. THE EVENT DID NOT HAVE AN IMPACT ON THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: ROD (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TABLE TOP ROD CUTTER AND BENDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266364 ↗
• MalfunctionOct 12, 2020Mechanical Problem; No Fail-Safe Mechanism; Mechanical Problem; No Fail-Safe Mechanism

  IT WAS REPORTED THAT ON (B)(6) 2020, THE END JOINT OF TABLE TOP ROD CUTTER AND BENDER HAS BECOME TO STIFF TO PROPERLY FUNCTION. CUTTER ARM WILL NO LONGER FREELY OPEN AND CLOSE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) TABLE TOP ROD CUTTER AND BENDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10665250 ↗
• MalfunctionJan 12, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS USED IN SURGERY FOR THE THORACOLUMBAR KYPHOSIS ON (B)(6) 2016. AFTER THE SURGEON INSERTED TOTAL OF TWENTY-FIVE (25) SCREWS, HE SELECTED COCR RODS INSTEAD OF TI RODS. BECAUSE THE COUNTER HANDLE WAS NOT AVAILABLE, THE SURGEON CONNECTED ONLY THE CUTTING HANDLE WITH THE ROD CUTTER. FIRST HE CUT THE DEPUY ROD TO BE APPROXIMATELY 350 MM. THE NURSE PUT HER WEIGHT TO THE ROD CUTTER UNIT AND FINISHED BY USING THE COUNTER. NEXT, THE SURGEON TRIED TO CUT THE SECOND ROD. WHEN THE ROD WAS CUT, THE SCREW ON THE CUTTING HANDLE BROKE. THE CHIPPED PIECE REMAINED IN THE MAIN PART OF THE DEVICE. THE SURGERY WAS COMPLETED WITHOUT DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES: ROD (QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6246091 ↗
• MalfunctionDec 12, 2016Break; Material Fragmentation; Break; Material Fragmentation

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A ROD CUTTER BROKE INTRAOPERATIVELY ON (B)(6) 2016 DURING AN UNKNOWN PROCEDURE. ALL FRAGMENTS WERE REMOVED AND NONE REMAINED BEHIND IN THE PATIENT. THERE WAS NO PROLONGATION OF SURGERY AND THE PATIENT OUTCOME WAS STABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6167090 ↗