BIOSURE 72201787Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010611833), received between Apr 19, 2025 and Jun 13, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BIOSURE SCREW BROKE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22200117 ↗
• MalfunctionApr 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE BIOSURE HA SCREW SNAPPED IN HALF DURING INSERTION. ONE HALF OF THE SCREW REMAINED SECURED IN THE PATIENT, WHILE THE OTHER HALF WAS RETRIEVED AS IT WAS STILL ATTACHED TO THE BIOSURE DRIVER. THE PROCEDURE WAS COMPLETED USING THE SAME FAULTY DEVICE, AND THE SURGEON PROCEEDED WITH A COMPETITOR DEVICE FROM ORTHO SOLUTIONS¿A MEMO STAPLE. AN 8 SCREW 10 MM X 5 MM WAS USED TO PREPARE THE INSERTION SITE, WHICH WAS ALSO CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21870064 ↗

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