BIOSURE 72201780Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010611765), received between Jul 2, 2019 and Sep 5, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K080358); they may or may not involve this specific model.

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.

• InjurySep 5, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL KNEE ARTHROSCOPY, THE TIP OF THE BIOSURE ANCHOR BROKE WHEN THE ANCHOR WAS FORCED, PREVENTING FIXATION OF THE GRAFT. THE ANCHOR BECAME LOOSE AND WAS COMING OUT OF THE TUNNEL WHEN REMOVING THE SCREW DRIVER WITH THE WIRE. THE ANCHOR LEFT NO FRAGMENT ON THE CAVITY. THE PROCEDURE WAS COMPLETED USING A LARGER SCREW AS A S+N BACKUP. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153232 ↗
• MalfunctionJul 2, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT (RIGHT KNEE) THE THREAD OF THE SCREW BROKE DURING THE IMPLANTATION, THE PIECES WERE REMOVED USING TWEEZERS. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8756190 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080358. One submission often covers many models, so check the product and lot details in each record.

• Z-0957-2026 · Nov 24, 2025 · Open, Classified
  BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
• Z-1225-2012 · Feb 6, 2012 · Terminated
  Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm Catalog Number: 72201772. The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue