BIOSURE 72201771Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010611673), received between Nov 21, 2017 and Aug 22, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY, WHEN REINFORCING THE LATERAL LIGAMENT, A TUNNEL WAS MADE TO FIX IT IN THE MEDIAL, WHEN TRYING TO PLACE THE BIOSURE SCREW 7X20 MM, IT BROKE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SCREW 6MM X 20MM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039270 ↗
• MalfunctionApr 29, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIOSURE SCREW BROKE AT THE MOMENT OF FINAL FIXATION. THE BROKEN PIECES WERE REMOVED FORM PATIENT. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209959 ↗
• MalfunctionDec 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BIOSURE BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9491315 ↗
• MalfunctionDec 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BIOSURE BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9490384 ↗
• MalfunctionMay 10, 2019Break

  IT WAS REPORTED THAT DURING SURGERY, THE SCREW BROKE WHILE INSERTING. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8601452 ↗
• MalfunctionJun 29, 2018Break

  IT WAS REPORTED THAT WHEN THREAD THE LAST TWO TURNS THE DR HAS A FEELING WEAKNESS, WITH THE SUBSEQUENT BREAKAGE OF THE SCREW CORE (WHERE THE SCREWDRIVER IS PLACED) TO THE OUTSIDE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7649415 ↗
• MalfunctionNov 21, 2017Break

  IT WAS REPORTED THAT THE BIOSURE BROKE WHEN TRYING TO INSERT IT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7048704 ↗

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