HOFFMANN 4933-0-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327094640), received between Mar 25, 2022 and Jun 23, 2026 — classified as 5 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Mechanical Jam

  THE QUICK-RELEASE MECHANISM FOR THE MOVABLE RING COULD NOT BE RELEASED FROM THE TRANSPORT STRUT AFTER THE FRAME HAD ALREADY BEEN ASSEMBLED AND WAS STUCK. THIS OCCURRED BEFORE THE FRAME WAS DISASSEMBLED FROM THE PATIENT. THEY USED A DIFFERENT STRUT FROM THE SET.

  Patient problems: Insufficient Information

  MAUDE report 25597833 ↗
• InjuryOct 9, 2024Use of Device Problem; Use of Device Problem

  AS REPORTED: "BONE TRANSPORT STRUTS CUT TO TRANSITION TO BONE LENGTHENING. AFTER THE CUT BELOW THEY PIECE COULD NOT GET EXTRACTED. CASE TYPE: BONE TRANSPORT DOCKING. REQUESTING FURTHER INFORMATION ON PIECE LEFT IN PATIENT." THE CASE WAS DELAYED BY 20 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 20412184 ↗
• InjuryOct 9, 2024Use of Device Problem; Use of Device Problem

  AS REPORTED: "BONE TRANSPORT STRUTS CUT TO TRANSITION TO BONE LENGTHENING. AFTER THE CUT BELOW THEY PIECE COULD NOT GET EXTRACTED. CASE TYPE: BONE TRANSPORT DOCKING. REQUESTING FURTHER INFORMATION ON PIECE LEFT IN PATIENT." THE CASE WAS DELAYED BY 20 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 20411970 ↗
• InjuryOct 9, 2024Use of Device Problem; Use of Device Problem

  AS REPORTED: "BONE TRANSPORT STRUTS CUT TO TRANSITION TO BONE LENGTHENING. AFTER THE CUT BELOW THEY PIECE COULD NOT GET EXTRACTED. CASE TYPE: BONE TRANSPORT DOCKING. REQUESTING FURTHER INFORMATION ON PIECE LEFT IN PATIENT." THE CASE WAS DELAYED BY 20 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 20411915 ↗
• InjurySep 4, 2024Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  AS REPORTED: "BONE TRANSPORT STRUTS CUT TO TRANSITION TO BONE LENGTHENING. AFTER THE CUT BELOW THEY PIECE COULD NOT GET EXTRACTED. CASE TYPE: BONE TRANSPORT DOCKING REQUESTING FURTHER INFORMATION ON PIECE LEFT IN PATIENT." THE CASE WAS DELAYED BY 20 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 20141102 ↗
• MalfunctionJan 30, 2023Mechanical Jam; Mechanical Jam

  AS REPORTED: "DURING SURGERY, IT WAS NOTICED THAT THE SHUTTER OF THE HOFFMANN LRF STRUT WAS BLOCKED AND COULD NOT BE MOVED. THE AFFECTED PRODUCT WAS NEW AND ERROR COULD NOT BE SOLVED. REPLACEMENT WAS AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264705 ↗
• MalfunctionNov 29, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A BIFOCAL BONE TRANSPORT DUE TO A SEPTIC TIBIA FRACTURE PREVIOUSLY TREATED WITH TWO PLATES. THE RESECTION WAS AROUND 9 CM AND THE SURGEON DECIDED TO DO TWO OSTEOTOMIES. FOR THIS REASON SIX BONE TRANSPORT RODS WERE USED. AFTER THE POSITIONING OF THE FRAME, THE LENGTH NEEDED TO BE CORRECTED, HOWEVER, WHEN THE THE DISTAL LOCKING COMPONENTS WERE UNLOCKED, (WITH RED WASHERS) THEY WERE NOT ABLE TO BE LOCKED AGAIN. THIS RESULTED IN A 45 MINUTE DELAY TO THE SURGERY. THIS WAS THE FIRST SURGERY WITH EXTERNAL FIXATOR BUT NOT THE FIRST ONE FOR THE PATIENT. THE PATIENT WAS PREVIOUSLY TREATED WITH TWO PLATES, WHICH WERE REMOVED DUE TO SEPTIC PSEUDOARTHROSIS. AFTER A RESECTION THE EXTERNAL FIXATOR WAS APPLIED FOR BONE TRANSPORT PROCEDURE. NO PROBLEM FOR THE PATIENT UNTIL NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880462 ↗
• MalfunctionNov 29, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A BIFOCAL BONE TRANSPORT DUE TO A SEPTIC TIBIA FRACTURE PREVIOUSLY TREATED WITH TWO PLATES. THE RESECTION WAS AROUND 9 CM AND THE SURGEON DECIDED TO DO TWO OSTEOTOMIES. FOR THIS REASON SIX BONE TRANSPORT RODS WERE USED. AFTER THE POSITIONING OF THE FRAME, THE LENGTH NEEDED TO BE CORRECTED, HOWEVER, WHEN THE THE DISTAL LOCKING COMPONENTS WERE UNLOCKED, (WITH RED WASHERS) THEY WERE NOT ABLE TO BE LOCKED AGAIN. THIS RESULTED IN A 45 MINUTE DELAY TO THE SURGERY. THIS WAS THE FIRST SURGERY WITH EXTERNAL FIXATOR BUT NOT THE FIRST ONE FOR THE PATIENT. THE PATIENT WAS PREVIOUSLY TREATED WITH TWO PLATES, WHICH WERE REMOVED DUE TO SEPTIC PSEUDOARTHROSIS. AFTER A RESECTION THE EXTERNAL FIXATOR WAS APPLIED FOR BONE TRANSPORT PROCEDURE. NO PROBLEM FOR THE PATIENT UNTIL NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880305 ↗
• MalfunctionNov 29, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A BIFOCAL BONE TRANSPORT DUE TO A SEPTIC TIBIA FRACTURE PREVIOUSLY TREATED WITH TWO PLATES. THE RESECTION WAS AROUND 9CM AND THE SURGEON DECIDED TO DO TWO OSTEOTOMIES. FOR THIS REASON SIX BONE TRANSPORT RODS WERE USED. AFTER THE POSITIONING OF THE FRAME, THE LENGTH NEEDED TO BE CORRECTED, HOWEVER, WHEN THE DISTAL LOCKING COMPONENTS WERE UNLOCKED, (WITH RED WASHERS) THEY WERE NOT ABLE TO BE LOCKED AGAIN. THIS RESULTED IN A 45 MINUTE DELAY TO THE SURGERY. THIS WAS THE FIRST SURGERY WITH EXTERNAL FIXATOR BUT NOT THE FIRST ONE FOR THE PATIENT. THE PATIENT WAS PREVIOUSLY TREATED WITH TWO PLATES, WHICH WERE REMOVED DUE TO SEPTIC PSEUDOARTHROSIS. AFTER A RESECTION THE EXTERNAL FIXATOR WAS APPLIED FOR BONE TRANSPORT PROCEDURE. NO PROBLEM FOR THE PATIENT UNTIL NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880293 ↗
• MalfunctionNov 29, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A BIFOCAL BONE TRANSPORT DUE TO A SEPTIC TIBIA FRACTURE PREVIOUSLY TREATED WITH TWO PLATES. THE RESECTION WAS AROUND 9CM AND THE SURGEON DECIDED TO DO TWO OSTEOTOMIES. FOR THIS REASON SIX BONE TRANSPORT RODS WERE USED. AFTER THE POSITIONING OF THE FRAME, THE LENGTH NEEDED TO BE CORRECTED, HOWEVER, WHEN THE DISTAL LOCKING COMPONENTS WERE UNLOCKED, (WITH RED WASHERS) THEY WERE NOT ABLE TO BE LOCKED AGAIN. THIS RESULTED IN A 45 MINUTE DELAY TO THE SURGERY. THIS WAS THE FIRST SURGERY WITH EXTERNAL FIXATOR BUT NOT THE FIRST ONE FOR THE PATIENT. THE PATIENT WAS PREVIOUSLY TREATED WITH TWO PLATES, WHICH WERE REMOVED DUE TO SEPTIC PSEUDOARTHROSIS. AFTER A RESECTION THE EXTERNAL FIXATOR WAS APPLIED FOR BONE TRANSPORT PROCEDURE. NO PROBLEM FOR THE PATIENT UNTIL NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880264 ↗
• MalfunctionNov 29, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A BIFOCAL BONE TRANSPORT DUE TO A SEPTIC TIBIA FRACTURE PREVIOUSLY TREATED WITH TWO PLATES. THE RESECTION WAS AROUND 9 CM AND THE SURGEON DECIDED TO DO TWO OSTEOTOMIES. FOR THIS REASON SIX BONE TRANSPORT RODS WERE USED. AFTER THE POSITIONING OF THE FRAME, THE LENGTH NEEDED TO BE CORRECTED, HOWEVER, WHEN THE DISTAL LOCKING COMPONENTS WERE UNLOCKED, (WITH RED WASHERS) THEY WERE NOT ABLE TO BE LOCKED AGAIN. THIS RESULTED IN A 45 MINUTE DELAY TO THE SURGERY. THIS WAS THE FIRST SURGERY WITH EXTERNAL FIXATOR BUT NOT THE FIRST ONE FOR THE PATIENT. THE PATIENT WAS PREVIOUSLY TREATED WITH TWO PLATES, WHICH WERE REMOVED DUE TO SEPTIC PSEUDOARTHROSIS. AFTER A RESECTION THE EXTERNAL FIXATOR WAS APPLIED FOR BONE TRANSPORT PROCEDURE. NO PROBLEM FOR THE PATIENT UNTIL NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880213 ↗
• MalfunctionNov 29, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A BIFOCAL BONE TRANSPORT DUE TO A SEPTIC TIBIA FRACTURE PREVIOUSLY TREATED WITH TWO PLATES. THE RESECTION WAS AROUND 9 CM AND THE SURGEON DECIDED TO DO TWO OSTEOTOMIES. FOR THIS REASON SIX BONE TRANSPORT RODS WERE USED. AFTER THE POSITIONING OF THE FRAME, THE LENGTH NEEDED TO BE CORRECTED, HOWEVER, WHEN THE THE DISTAL LOCKING COMPONENTS WERE UNLOCKED, (WITH RED WASHERS) THEY WERE NOT ABLE TO BE LOCKED AGAIN. THIS RESULTED IN A 45 MINUTE DELAY TO THE SURGERY. THIS WAS THE FIRST SURGERY WITH EXTERNAL FIXATOR BUT NOT THE FIRST ONE FOR THE PATIENT. THE PATIENT WAS PREVIOUSLY TREATED WITH TWO PLATES, WHICH WERE REMOVED DUE TO SEPTIC PSEUDOARTHROSIS. AFTER A RESECTION THE EXTERNAL FIXATOR WAS APPLIED FOR BONE TRANSPORT PROCEDURE. NO PROBLEM FOR THE PATIENT UNTIL NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880178 ↗
• MalfunctionNov 29, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A HANDS ON DEMONSTRATION IT WAS NOTED THAT THE AFFECTED BONE TRANSPORT STRUT DID NOT SEEM TO BE ABLE TO REACH IT'S MAXIMUM LENGTH, EVEN WHEN QUICK LOCK MECHANISMS WERE BOTH DISENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876520 ↗
• MalfunctionNov 18, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "PATIENT CAME IN AND ONE OF THE STRUTS WAS NOT TRANSPORTING MAKING THE TRANSPORTING BONE SHIFT AND NOT LINE UP TO DOCKING SITE. PATIENT HAD TO SPEND AN EXTRA HOUR AS THE SURGEON HAD REPLACE THE BROKEN STRUT IN CLINIC. THIS MAY DELAY HIS DOCKING PROCEDURE IN THE FUTURE."

  Patient problems: Failure of Implant

  MAUDE report 15825314 ↗
• MalfunctionNov 18, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "PATIENT CAME IN AND ONE OF THE STRUTS WAS NOT TRANSPORTING MAKING THE TRANSPORTING BONE SHIFT AND NOT LINE UP TO DOCKING SITE. PATIENT HAD TO SPEND AN EXTRA HOUR AS THE SURGEON HAD REPLACE THE BROKEN STRUT IN CLINIC. THIS MAY DELAY HIS DOCKING PROCEDURE IN THE FUTURE."

  Patient problems: Failure of Implant

  MAUDE report 15825190 ↗
• MalfunctionNov 18, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "PATIENT CAME IN AND ONE OF THE STRUTS WAS NOT TRANSPORTING MAKING THE TRANSPORTING BONE SHIFT AND NOT LINE UP TO DOCKING SITE. PATIENT HAD TO SPEND AN EXTRA HOUR AS THE SURGEON HAD REPLACE THE BROKEN STRUT IN CLINIC. THIS MAY DELAY HIS DOCKING PROCEDURE IN THE FUTURE."

  Patient problems: Failure of Implant

  MAUDE report 15825183 ↗
• MalfunctionNov 18, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "PATIENT CAME IN FOR FOLLOW UP ON THE BONE TRANSPORT FRAME. THE SURGEON THEN NOTICED THE BT STRUT HAD MALFUNCTIONED AND WAS NO LONG MOVING OR TRANSPORTING. THE OTHER 2 STRUTS DID MOVE MAKING THE TRANSPORTING BONE SHIFT ANTERIOR TO POSTERIOR. WE WERE ABLE TO SWAP OUT THE BROKEN STRUT FOR ANOTHER STRUT. THE PATIENT HAD TO SPEND ANOTHER HOUR IN THE CLINIC WHILE WE EXCHANGED HIS STRUT AND HAD TO GO BACK AND GET FOLLOW UP X-RAYS." UPDATE: WE USED ALL STRYKER HOFFMAN COMPONENTS. 1 HALF RING, 3 CIRCULAR RINGS AND 1 FOOT PLATE WITH ROCKER SHOES, 4 STRUTS WERE USED IN TOTAL. THE PATIENT WAS INSTRUCTED TO KEEP WEIGH BARRING TO A MINIMUM. WE ADDED ROCKER SHOES A WEEK AFTER IN THE CLINIC TO HELP WITH ALLOWING THE PATIENT TO REST HIS FOOT ON THE GROUND. THE OVERALL HEALTH OF THE PATIENT IS GOOD AND BONE QUALITY WAS FINE. THE FRAMES WAS ATTACHED TO THE PATIENTS TIBIA. ACTIVITY LEVEL OF THE PATIENT WAS LOW. THE PATIENT DID NOT COMPLAIN. THE SURGEON NOTICED THE STRUTS NOT WORKING CORRECTLY AFTER X-RAYS WERE PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 15825049 ↗
• MalfunctionNov 18, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "PATIENT CAME IN FOR FOLLOW UP ON THE BONE TRANSPORT FRAME. THE SURGEON THEN NOTICED THE BT STRUT HAD MALFUNCTIONED AND WAS NO LONG MOVING OR TRANSPORTING. THE OTHER 2 STRUTS DID MOVE MAKING THE TRANSPORTING BONE SHIFT ANTERIOR TO POSTERIOR. WE WERE ABLE TO SWAP OUT THE BROKEN STRUT FOR ANOTHER STRUT. THE PATIENT HAD TO SPEND ANOTHER HOUR IN THE CLINIC WHILE WE EXCHANGED HIS STRUT AND HAD TO GO BACK AND GET FOLLOW UP X-RAYS." UPDATE: WE USED ALL STRYKER HOFFMAN COMPONENTS. 1 HALF RING, 3 CIRCULAR RINGS AND 1 FOOT PLATE WITH ROCKER SHOES, 4 STRUTS WERE USED IN TOTAL. THE PATIENT WAS INSTRUCTED TO KEEP WEIGH BARRING TO A MINIMUM. WE ADDED ROCKER SHOES A WEEK AFTER IN THE CLINIC TO HELP WITH ALLOWING THE PATIENT TO REST HIS FOOT ON THE GROUND. THE OVERALL HEALTH OF THE PATIENT IS GOOD AND BONE QUALITY WAS FINE. THE FRAMES WAS ATTACHED TO THE PATIENTS TIBIA. ACTIVITY LEVEL OF THE PATIENT WAS LOW. THE PATIENT DID NOT COMPLAIN. THE SURGEON NOTICED THE STRUTS NOT WORKING CORRECTLY AFTER X-RAYS WERE PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 15825046 ↗
• MalfunctionNov 18, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "PATIENT CAME IN FOR FOLLOW UP ON THE BONE TRANSPORT FRAME. THE SURGEON THEN NOTICED THE BT STRUT HAD MALFUNCTIONED AND WAS NO LONG MOVING OR TRANSPORTING. THE OTHER 2 STRUTS DID MOVE MAKING THE TRANSPORTING BONE SHIFT ANTERIOR TO POSTERIOR. WE WERE ABLE TO SWAP OUT THE BROKEN STRUT FOR ANOTHER STRUT. THE PATIENT HAD TO SPEND ANOTHER HOUR IN THE CLINIC WHILE WE EXCHANGED HIS STRUT AND HAD TO GO BACK AND GET FOLLOW UP X-RAYS." UPDATE: WE USED ALL STRYKER HOFFMAN COMPONENTS. 1 HALF RING, 3 CIRCULAR RINGS AND 1 FOOT PLATE WITH ROCKER SHOES, 4 STRUTS WERE USED IN TOTAL. THE PATIENT WAS INSTRUCTED TO KEEP WEIGH BARRING TO A MINIMUM. WE ADDED ROCKER SHOES A WEEK AFTER IN THE CLINIC TO HELP WITH ALLOWING THE PATIENT TO REST HIS FOOT ON THE GROUND. THE OVERALL HEALTH OF THE PATIENT IS GOOD AND BONE QUALITY WAS FINE. THE FRAMES WAS ATTACHED TO THE PATIENTS TIBIA. ACTIVITY LEVEL OF THE PATIENT WAS LOW. THE PATIENT DID NOT COMPLAIN. THE SURGEON NOTICED THE STRUTS NOT WORKING CORRECTLY AFTER X-RAYS WERE PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 15825044 ↗
• MalfunctionAug 25, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "PATIENT CAME IN AND ONE OF THE STRUTS WAS NOT TRANSPORTING MAKING THE TRANSPORTING BONE SHIFT AND NOT LINE UP TO DOCKING SITE. PATIENT HAD TO SPEND AN EXTRA HOUR AS THE SURGEON HAD REPLACE THE BROKEN STRUT IN CLINIC. THIS MAY DELAY HIS DOCKING PROCEDURE IN THE FUTURE"

  Patient problems: Failure of Implant

  MAUDE report 15298912 ↗
• MalfunctionAug 23, 2022Break; Fracture; Mechanical Jam; Break; Fracture; Mechanical Jam

  AS REPORTED: "PATIENT CAME IN FOR FOLLOW UP ON THE BONE TRANSPORT FRAME. THE SURGEON THEN NOTICED THE BT STRUT HAD MALFUNCTIONED AND WAS NO LONG MOVING OR TRANSPORTING. THE OTHER 2 STRUTS DID MOVE MAKING THE TRANSPORTING BONE SHIFT ANTERIOR TO POSTERIOR. WE WERE ABLE TO SWAP OUT THE BROKEN STRUT FOR ANOTHER STRUT. THE PATIENT HAD TO SPEND ANOTHER HOUR IN THE CLINIC WHILE WE EXCHANGED HIS STRUT AND HAD TO GO BACK AND GET FOLLOW UP X-RAYS."

  Patient problems: Failure of Implant

  MAUDE report 15274731 ↗
• InjuryMar 25, 2022Break; Fracture; Break; Fracture

  THE LOCKING MECHANISM FOR THE MOVING RING DEROTATION POST ON THE MEDIAL SIDE BROKE, A NEW STRUT WAS EXCHANGED FOR THE BROKEN STRUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13910437 ↗