HOFFMANN 4922-1-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540680983), received between Sep 10, 2018 and Sep 10, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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.

• MalfunctionSep 10, 2018Loose or Intermittent Connection; Device Slipped

  THE HOFFMANN 3 KICKSTAND FOR AN ANKLE DELTA DFAME CONTINUES TO LOOSEN AND SLIDE OUT. DELTA COUPLINGS WE¿RE FULLY TIGHTENED AND HAS HAPPENED BEFORE PER THE SURGEON (NEVER NOTIFIED OF PRIOR ISSUE) WHEN CONNECTING THE KICKSTAND TO THE TRANSFIXING PIN OR TO THE 11 X 350 MM CONNECTING RODS. HE FEELS AS IF THE COUPLINGS WERE TIGHT AS POSSIBLE WITH BOTH THE T HANDLE AND WRENCH. ISSUE WAS NOTICED POST SURGERY WHEN THE STABILITY OF THE FRAME DID NOT REMAIN INTACT 2 DAYS POST SURGERY.

  Patient problems: No Information

  MAUDE report 7861900 ↗
• MalfunctionSep 10, 2018Loose or Intermittent Connection; Device Slipped

  THE HOFFMANN 3 KICKSTAND FOR AN ANKLE DELTA DFAME CONTINUES TO LOOSEN AND SLIDE OUT. DELTA COUPLINGS WE¿RE FULLY TIGHTENED AND HAS HAPPENED BEFORE PER THE SURGEON (NEVER NOTIFIED OF PRIOR ISSUE) WHEN CONNECTING THE KICKSTAND TO THE TRANSFIXING PIN OR TO THE 11X 350 MM CONNECTING RODS. HE FEELS AS IF THE COUPLINGS WERE TIGHT AS POSSIBLE WITH BOTH THE T HANDLE AND WRENCH. ISSUE WAS NOTICED POST SURGERY WHEN THE STABILITY OF THE FRAME DID NOT REMAIN INTACT 2 DAYS POST SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7861899 ↗