BIOSURE 72203252Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885554027181), received between Nov 1, 2021 and Mar 20, 2023 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2023Break; Break

  IT WAS REPORTED THAT DURING A THR PROCEDURE, THE TIP OF THE FLEXIBLE TAP BIOSURE BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16575873 ↗
• MalfunctionNov 1, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL BTB PROCEDURE, AFTER USING THE FLEXIBLE TAP BIOSURE 6MM TO THREAD THE FEMORAL TUNNEL AND THE BONE PLUG, WHEN PLACING IT ON THE TABLE, IT WAS NOTICED THAT IT WAS BROKEN, NO PART REMAINED INSIDE THE PATIENT AND ALL PARTS WERE GLUED ON THE INSTRUMENT, ALL THE NECESSARY DEPTH COULD BE MADE FOR THE SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12729559 ↗