BIORCI 7207558Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010426215), received between Apr 20, 2018 and May 2, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 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.

• MalfunctionMay 2, 2018Break

  IT WAS REPORTED THAT THE TIP OF SCREW BROKE AT THE FEMUR. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7481944 ↗
• MalfunctionApr 26, 2018Break

  IT WAS REPORTED THAT SCREW BROKE WHILE FIXED IN THE FEMORAL TUNNEL. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO MAJOR DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7465889 ↗
• MalfunctionApr 20, 2018Break

  IT WAS REPORTED THAT THE SCREW BROKE WHEN ENTERING THE TUNNEL, WITHOUT ANY PRESSURE ON IT, 15 MIN OF DELAY, ANOTHER SCREW 8X30MM USED INSTEAD. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7449068 ↗