BIOSURE 72204410Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885554036862), received between Jun 16, 2018 and Aug 23, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K142948); 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.

• MalfunctionAug 23, 2024Break; Break

  IT WAS REPORTED THAT, DURING A RE-REVISION ACL RECONSTRUCTION PROCEDURE, THE BIOSURE REGENESORB SCREW BROKE WHILE SCREWING IT IN, BROKEN PIECES WERE REMOVED USING A GRASPER. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD IN THE ORIGINAL HOLE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055157 ↗
• MalfunctionJan 3, 2024Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORSURE SCREW WAS WEAKENED. WHEN PASSING THE SCREW, IT BECAME UNTHREADED AND REMAINED SMOOTH. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. UPON INVESTIGATION, IT WAS FOUND A FRACTURE OF THE THREADS OF THE PROXIMAL THIRD OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18441269 ↗
• InjuryMay 25, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, AFTER DRILLING THE TIBIAL TUNNEL WITH A 10MM DRILL, THE BIOSURE REGENESORB SCREW WAS INSERTED WITH THE NITINOL GUIDE AND, WHEN IMPLANTING, IT BROKE INTO 4 PIECES, THE GUIDE AND THE SCREW PARTS WERE REMOVED OF THE TIBIAL TUNNEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 30 MINUTES USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14493770 ↗
• MalfunctionAug 1, 2018Break

  IT WAS REPORTED THAT THE SCREW BROKE INSIDE WHILE PUTTING IN THE TUNNEL. NO PATIENT INJURY WAS REPORTED. IT IS UNKNOWN IF THERE WAS A BACK UP OR IF THERE WAS A DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7739197 ↗
• MalfunctionJun 16, 2018Break

  IT WAS REPORTED THAT UNIT GOT DAMAGED/BREAKAGE DURING THE SURGERY. ALL BROKEN PIECES WERE REMOVED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7608438 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142948. 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.