HOFFMANN 4933-1-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252507789), received between May 21, 2024 and May 21, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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.

• InjuryMay 21, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WERE 3 WIRE BREAKAGES. AFTER CONCLUSION OF THE INVESTIGATION, IT WAS NOTED THAT THERE WAS A CLEAR INDICATION THAT THE WIRE BOLT WASN¿T TIGHTENED ENOUGH.

  Patient problems: Failure of Implant; Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 19367325 ↗
• InjuryMay 21, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WERE 3 WIRE BREAKAGES. AFTER CONCLUSION OF THE INVESTIGATION, IT WAS NOTED THAT THERE WAS A CLEAR INDICATION THAT THE WIRE BOLT WASN¿T TIGHTENED ENOUGH.

  Patient problems: Failure of Implant; Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 19367322 ↗