INTRAMEDULLARY ROD REMOVAL HOOKWITH T-HANDLE 32-401111Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05019279469246), received between Jun 11, 2019 and Jan 12, 2024 — classified as 14 malfunctions.

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

• MalfunctionJan 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY WHILE TRIALLING THE TIBIA AND POSITIONING FOR TIBIAL KEEL CUT, THE TEA HANDLE, HOOK BROKE OFF. THE HOOK PORTION OF THE HANDLE WAS EASILY RETRIEVED ON THE FIELD. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501183 ↗
• MalfunctionAug 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE INTRAMEDULLARY ROD BROKE DURING A PROCEDURE. THE BROKEN PIECE WAS RETRIEVED AND DID NOT FALL INTO THE PATIENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640802 ↗
• MalfunctionJul 7, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17276883 ↗
• MalfunctionFeb 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT WHILE USING THE T-HANDLE TO REMOVE 0 SPIGOT FROM PATIENT DURING BILATERAL UNICONDULAR KNEE REPLACEMENT, PEG FOR INSERTION INTO THE SPIGOT SHEARED OFF AT THE CONNECTION POINT TO THE T-HANDLE. NO IMPACT ON PATIENT WAS NOTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16370100 ↗
• MalfunctionFeb 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT: THE HOOK FOR REMOVING THE IM ROD BROKE OFF DURING THE OPERATION, NOTHING REMAINED IN THE PATIENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT. AT THE SAME TIME, A TIP OF THE CONNECTING PIECE BROKE OFF DURING THE OPERATION. NOTHING REMAINED IN THE PATIENT AND COULD BE REMOVED FROM THE IM. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16361018 ↗
• MalfunctionJan 25, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16239768 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15507648 ↗
• MalfunctionSep 27, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PIN OF THE HANDLE HOOK BROKE. NO IMPACT OR CONSEQUENCES TO THE PATIENT OR THE USER WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15493202 ↗
• MalfunctionAug 8, 2022Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. NO IMPACT OR CONSEQUENCE TO THE PATIENT HAVE BEEN REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15182367 ↗
• MalfunctionJun 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT WHILE TRYING TO REMOVE INTRAMEDULLARY ROD FROM FEMUR WITH THE T-HANDLE, THE TIP OF THE T-HANDLE BROKE. NO FURTHER PATIENT OUTCOME PROVIDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14840866 ↗
• MalfunctionNov 2, 2021Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT: THE IM ROD REMOVAL HOOK BROKE WHEN THE DOCTOR WAS TRYING TO REMOVE THE IM ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12735620 ↗
• MalfunctionJun 10, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING SURGERY THE HOOK OF INSTRUMENT BROKE OFF WHEN SURGEON WENT TO PULL THE ROD OUT OF THE FEMUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11973190 ↗
• MalfunctionNov 11, 2019Break; Break

  IT WAS REPORTED THAT WHEN THE SURGEON WAS TRYING TO REMOVE THE INTRA MEDULLAR RODE DURING SURGERY, THE LITTLE HOOK BROKE OFF AND FELL ON THE FLOOR. NO MISUSED OF HOOK WAS MADE. NO PART FELL IN THE PATIENT. THE SURGERY WAS NOT DELAYED, THE HOSPITAL HAD ANOTHER KIT READY TO USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9303606 ↗
• MalfunctionJun 11, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A PARTIAL LEFT KNEE REPLACEMENT PROCEDURE, THE SURGEON WAS USING THE T-HANDLE TO REMOVE INTRAMEDULLARY ROD FROM THE PATIENT'S FEMUR WHEN THE LITTLE HOOK BROKE. ALL PIECES HAVE BEEN RETRIEVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8686367 ↗