HOFFMANN 4933-8-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613252611011), received between Oct 3, 2019 and Sep 9, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Break” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE FOUR WIRE BREAKAGES ON A FRAME. THE WIRES BROKE AT THE INTERFACE WITH THE WIRE BOLT. THE PRIMARY SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS WEIGHT BEARING AND THERE WERE NO FALLS OR TRIPS TO CAUSE THE REPORTED EVENT. DURING THE REVISION SURGERY IT WAS REPORTED THAT ANOTHER WIRE IN THE PROXIMAL RING AT THE OLIVE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 23005063 ↗
• InjurySep 9, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE FOUR WIRE BREAKAGES ON A FRAME. THE WIRES BROKE AT THE INTERFACE WITH THE WIRE BOLT. THE PRIMARY SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS WEIGHT BEARING AND THERE WERE NO FALLS OR TRIPS TO CAUSE THE REPORTED EVENT. DURING THE REVISION SURGERY IT WAS REPORTED THAT ANOTHER WIRE IN THE PROXIMAL RING AT THE OLIVE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 23004196 ↗
• InjurySep 8, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE FOUR WIRE BREAKAGES ON A FRAME. THE WIRES BROKE AT THE INTERFACE WITH THE WIRE BOLT. THE PRIMARY SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS WEIGHT BEARING AND THERE WERE NO FALLS OR TRIPS TO CAUSE THE REPORTED EVENT. DURING THE REVISION SURGERY IT WAS REPORTED THAT ANOTHER WIRE IN THE PROXIMAL RING AT THE OLIVE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 22999300 ↗
• InjurySep 8, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE FOUR WIRE BREAKAGES ON A FRAME. THE WIRES BROKE AT THE INTERFACE WITH THE WIRE BOLT. THE PRIMARY SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS WEIGHT BEARING AND THERE WERE NO FALLS OR TRIPS TO CAUSE THE REPORTED EVENT. DURING THE REVISION SURGERY IT WAS REPORTED THAT ANOTHER WIRE IN THE PROXIMAL RING AT THE OLIVE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 22999299 ↗
• InjurySep 3, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT TWO BROKEN 1.8MM OLIVE WIRES IN PROXIMAL RING OF HLRF FRAME. IMMEDIATE FULL WEIGHT BEARING ON RIGHT SIDE (FRAME SIDE). NON-WEIGHT BEARING ON LEFT SIDE ONE AT HLRF WIRE BOLT INTERFACE AND ONE IN THE BONE. PATIENT NOTICED FIRST BROKEN WIRE AT HOME ON (B)(6). PATIENT PHONED SURGEON AND WAS ADVISED (B)(6) AND TO COME STRAIGHT TO CLINIC. PATIENT ATTENDED CLINIC THAT AFTERNOON AND SECOND BROKEN WIRE WAS IDENTIFIED. PATIENT RETURNED TO THEATRE, THE TWO BROKEN WIRES WERE REMOVED AND REPLACED WITH THREE NEW WIRES. WIRE LOT NUMBERS ARE NOT AVAILABLE AS THIS SECTION OF THE WIRE WAS CUT OFF AND DISCARDED WHEN CUTTING TO LENGTH DURING INITIAL BUILD. NO BONE QUALITY CONCERNS AND PATIENT HAS TYPE 2 DIABETES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22949694 ↗
• InjuryAug 29, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT TWO BROKEN 1.8MM OLIVE WIRES IN PROXIMAL RING OF HLRF FRAME. IMMEDIATE FULL WEIGHT BEARING ON RIGHT SIDE (FRAME SIDE). NON WEIGHT BEARING ON LEFT SIDE ONE AT HLRF WIRE BOLT INTERFACE AND ONE IN THE BONE. PATIENT NOTICED FIRST BROKEN WIRE AT HOME ON 29TH JULY. PATIENT PHONED SURGEON AND WAS ADVISED NWB AND TO COME STRAIGHT TO CLINIC. PATIENT ATTENDED CLINIC THAT AFTERNOON AND SECOND BROKEN WIRE WAS IDENTIFIED. PATIENT RETURNED TO THEATRE, THE TWO BROKEN WIRES WERE REMOVED AND REPLACED WITH THREE NEW WIRES. WIRE LOT NUMBERS ARE NOT AVAILABLE AS THIS SECTION OF THE WIRE WAS CUT OFF AND DISCARDED WHEN CUTTING TO LENGTH DURING INITIAL BUILD NO BONE QUALITY CONCERNS AND PATIENT HAS TYPE 2 DIABETES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22927144 ↗
• InjuryMay 15, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "PATIENT HAD WIRE BREAKAGE." ADDITIONALLY, IT WAS REPORTED THE PATIENT ALSO EXPERIENCED PAIN.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 19321244 ↗
• InjuryMar 23, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "2 WIRE BREAKAGES IN A HOFFMAN LRF ANKLE FRAME WHICH WAS PUT ON (B)(6). WIRE BREAKAGE OCCURRED WHEN PATIENT WAS AT HOME. PATIENT HAD BEEN WEIGHTBEARING ON CRUTCHES WITH THE FRAME. PATIENT EXPERIENCED PAIN. REOPERATION REQUIRED AS FIXATION FAILED."

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 18965295 ↗
• InjuryJun 13, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A WIRE BROKE ON A CIRCULAR FIXATION FRAME.

  Patient problems: Failure of Implant

  MAUDE report 17118186 ↗
• InjuryOct 4, 2019Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED: "A COUPLE OF PROXIMAL PINS IN THE TIBIA IN AN LRF CASE WERE LOOSE." ALSO REPORTED: "THE REVISION WAS DONE DUE TO LOOSENING OF THE THIN WIRES. THE WIRES THAT APPEARED LOOSE WERE REPLACED BY HALF PINS, WHICH BECAME STABLE."

  Patient problems: No Information

  MAUDE report 9156718 ↗
• InjuryOct 3, 2019Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED: "A COUPLE OF PROXIMAL PINS IN THE TIBIA IN AN LRF CASE WERE LOOSE." ALSO REPORTED: "THE REVISION WAS DONE DUE TO LOOSENING OF THE THIN WIRES. THE WIRES THAT APPEARED LOOSE WERE REPLACED BY HALF PINS, WHICH BECAME STABLE."

  Patient problems: No Code Available

  MAUDE report 9153697 ↗