HOFFMANN 4935-0-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327294200), received between May 29, 2018 and Sep 6, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K163656, K233741); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2018Break

  IT WAS REPORTED THAT PATIENT PRESENTED TO SURGEON'S OFFICE WITH A BROKEN LONG STRUT. THIS WAS NOT A ROUTINE FOLLOWUP VISIT. CAUSES OR CONTRIBUTORS TO STRUT BREAKAGE CURRENTLY UNKNOWN. A WIRE WAS UTILIZED TO HOLD THE STRUT IN PLACE UNTIL IT CAN BE REPLACED (B)(6) 2018 AS THE SURGEON IS AWAY UNTIL THAT DATE. REP WON'T BE ABLE TO GET ANY ADDITIONAL INFORMATION UNTIL ON OR AFTER (B)(6) 2018 WHEN HE CAN CONFER WITH THE SURGEON, BUT EXPECTS THE DEVICE TO BE AVAILABLE FOR RETURN AFTER THAT DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7853051 ↗
• MalfunctionJul 18, 2018Material Separation

  HEXAPOD STRUT. BLACK PIN DISENGAGED 1/4 OUT. PATIENT WAS ABLE TO PUSH IT BACK IN.

  Patient problems: No Code Available

  MAUDE report 7700734 ↗
• MalfunctionMay 29, 2018Break

  IT WAS REPORTED THAT UPON SCHEDULED REMOVAL OF THE EXTERNAL FIXATION CONSTRUCT ON PATIENT'S ANKLE (SIDE NOT REPORTED), A LARGE STRUT WAS OBSERVED TO BE BROKEN APART. THREE 2.0 WIRES WERE ALSO REPORTED BROKEN AT THE JUNCTION OF THE BOLT ADAPTORS. PREVIOUS FOLLOWUP VISITS BY THE PATIENT SHOWED THE ENTIRE CONSTRUCT INTACT.

  Patient problems: No Code Available

  MAUDE report 7551198 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163656, K233741. One submission often covers many models, so check the product and lot details in each record.

• Z-0288-2019 · Aug 28, 2018 · Terminated
  Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment
• Z-0291-2019 · Aug 28, 2018 · Terminated
  Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment
• Z-0290-2019 · Aug 28, 2018 · Terminated
  Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment
• Z-0289-2019 · Aug 28, 2018 · Terminated
  Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment
• Z-3240-2018 · Jul 26, 2018 · Terminated
  Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002