REEF L93572Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295261421), received between Dec 6, 2018 and Jan 18, 2023 — classified as 3 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJan 18, 2023Break; Break

  IT WAS REPORTED THAT THE SCREW THAT ATTACHES THE TO THE DEFINITIVE STEM TO THE DRILL FRAME SNAPPED INTO TWO PARTS DURING IMPACTION. I WAS PRESENT DURING THE PROCEDURE AND THE SURGEON SHARED THIS WITH ME IMMEDIATELY, BOTH PARTS OF THE SCREW WERE OBTAINED AND EASILY RETRIEVED FROM THE STEM AND FRAME. NO HARM WAS DONE TO THE PATIENT OR TO THE DEFINITIVE STEM. NO EXTRA TIME WAS ADDED TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194694 ↗
• MalfunctionJan 25, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT AT SOME POINT THE ARM HAS BECOME BENT OVER TIME AND NO LONGER TARGETS THE HOLES ON THE STEM WHILST IN SITU. I AM NOT SURE AT THIS POINT IF THIS WAS NOTICED DURING SURGERY. UNSURE OF SURGICAL DELAY. NO LOT NUMBER AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13341587 ↗
• MalfunctionDec 6, 2018Break; Break

  STEM BROKE.

  Patient problems: Not Applicable

  MAUDE report 8138248 ↗