NA 451-3004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886385012292), received between Feb 2, 2022 and Feb 3, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2022Break; Fracture; Break; Fracture

  THE FOLLOWING EVENT WAS REPORTED BY THE STRYKER REP: "THE HOFFMANN LRF FRAME WAS PUT ON THE PATIENT ON (B)(6) 2021 FOR AN ANKLE FUSION PROCEDURE TO PROTECT THE INTERNAL HARDWARE. PATIENT NOTIFIED THE SURGEON ON (B)(6) 2022 COMPLAINING OF A LOUD 'POP' OR A LOOSE 'CLICKING SOUND. FRAME WAS REMOVED ON THE FOLLOWING DAY (B)(6) 2022. EVERY WIRE BROKE AND NUTS LOOSENED UP. THE SURGEON MENTIONED THE PATIENT WAS NOT WALKING ON IT THROUGHOUT THE FEW WEEKS IT WAS ON."

  Patient problems: Failure of Implant

  MAUDE report 13446823 ↗
• InjuryFeb 2, 2022Break; Fracture; Break; Fracture

  THE FOLLOWING EVENT WAS REPORTED BY THE STRYKER REP: "THE HOFFMANN LRF FRAME WAS PUT ON THE PATIENT ON (B)(6) 2021 FOR AN ANKLE FUSION PROCEDURE TO PROTECT THE INTERNAL HARDWARE. PATIENT NOTIFIED THE SURGEON ON (B)(6) 2022 COMPLAINING OF A LOUD 'POP' OR A LOOSE 'CLICKING SOUND. FRAME WAS REMOVED ON THE FOLLOWING DAY (B)(6) 2022. EVERY WIRE BROKE AND NUTS LOOSENED UP. THE SURGEON MENTIONED THE PATIENT WAS NOT WALKING ON IT THROUGHOUT THE FEW WEEKS IT WAS ON."

  Patient problems: Failure of Implant

  MAUDE report 13423870 ↗