BIOSURE 7211137Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010559043), received between Oct 9, 2019 and May 1, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, A SCREW WAS FIXED WITH A GUIDE WIRE, AND AFTER REMOVING, IT BROKE. THE SPECIALIST TRIED TO PULL IT OUT WITH PLIERS AND A HAMMER, AND IT BROKE AGAIN. THE ENTIRE GRAFT WAS REMOVED, AND THE REMAINING PIECE OF GUIDE WIRE THAT NEEDED TO BE REMOVED CAME OUT WITH THE GRAFT BECAUSE IT WAS FIXED IN THE GRAFT AND IMPOSSIBLE TO REMOVE OTHERWISE. THE PROCEDURE WAS RESUMED, AFTER A 40-MIN SURGICAL DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062123 ↗
• MalfunctionOct 9, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE SURGERY THE PRODUCT TWISTED AND BROKE. THE PIECES WERE REMOVED FROM THE PATIENT BY TWEEZERS. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9173146 ↗