HOFFMANN 4941-1-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540492722), received between Mar 27, 2019 and Mar 27, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2019Difficult or Delayed Positioning; Mechanical Problem; Mechanical Jam; Difficult or Delayed Positioning

  AN 8-YEAR-OLD BOY WAS OPERATED WITH A CROOKED AND SHORTENED RIGHT UPPER ARM. A CORRECTION OSTEOTOMY AND PLACEMENT OF A DISTRACTION FIXATOR WAS PLANNED. FOR THIS THE HOSPITAL ORDERED AN EXTRA DISTRACTOR ROD AND 2 FIXATION CLAMPS FOR THE HOFFAMNN COMPACT FIXATEUR. DURING THE OPERATION, IT TURNED OUT THAT ONE OF THE CLAMPS WAS DIFFICULT TO OPEN AND OPERATE, THE SECOND WAS NOT FUNCTIONAL. MULTIPLE ATTEMPTS TO LOOSEN THE CLAMP SO THAT IT COULD BE OPENED OR CLOSED WERE FRUSTRATING. FINALLY, AFTER A PREVIOUS OSTEOTOMY, A CONVENTIONAL CONNECTING ROD HAD TO BE ATTACHED. AS A RESULT, THE BOY MUST GET THE PLANNED DISTRACTOR AFTER 1 WEEK IN A NEW ANESTHETIC. IT IS TO BE HOPED THAT THERE WILL BE NO CHANGE OF POSITION WITHIN THE SCOPE OF THE MANIPULATION OR THAT THE CALLUS WILL NOT BREAK OFF. THIS COULD JEOPARDIZE THE OVERALL OUTCOME OF THE OPERATION. REVISION IS PLANNED FOR (B)(6) 2019.SURGICAL DELAY OF 60 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8457271 ↗