BIOSURE 72201789Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010611857), received between Jul 10, 2018 and May 1, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, ONE (1) BIOSURE INTERFERENCE SCREW GOT BROKEN WHILE INSERTION. ALL THE BROKEN PIECES WERE REMOVED USING ARTERY FORCEPS AND SUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. IN THE ORIGINALLY DRILLED BONE HOLE. THE PATIENT'S STATUS IS SAFE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058711 ↗
• MalfunctionMar 3, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY AND LIGAMENT PROCEDURE, THE BIOSURE HA ANCHOR BROKE WHILE BEING IMPLANTED. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING A WRENCH AND FORCEPS, WITH THE SMALLER FRAGMENT DISCARDED BY THE HOSPITAL AFTER REMOVAL. SURGERY WAS COMPLETED USING A BACK-UP DEVICE, AND NO SURGICAL DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510104 ↗
• MalfunctionNov 10, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LCA SURGERY THE DEVICE BROKE WHEN THE DOCTOR WAS DOING THE GRAFT ATTACHMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9302686 ↗
• MalfunctionOct 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING THE SURGERY, WHEN THE SURGEON STARTED TO SCREW THERE WAS AN ISSUE WITH THE SCREW THREAD. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS SCREW BROKE INSIDE THE PATIENT WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9248327 ↗
• MalfunctionJul 10, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT THE DRIVER IS NOT SEATING INSIDE THE SCREW FULLY. STILL WHEN THEY TRIED ROTATING AND TO PUT THE SCREW IN THE BONE, THE SCREW DRIVER STARTED MOVING INSIDE THE SCREW. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7674501 ↗

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