BIOSCREW C8014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854014131), received between Jun 30, 2022 and Jun 30, 2022 — classified as 1 malfunction.

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

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, C8014, BIOSCREW 9MM X 25MM BIOABSORBABLE INTERFERENCE WAS BEING USED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED ¿TIP OF THE BIOSCREW WAS DAMAGED WHILE SCREWING THE SCREW ON THE GRAFT.¿ AFTER FURTHER ASSESSMENT QUESTIONING IT WAS FOUND THAT THE DEVICE DID FRAGMENT AND IT WAS RETRIEVED. IT WAS ALSO REPORTED THAT THE ¿PATIENT IS FINE." THERE WAS NO DELAY IN THE SURGERY AND THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATIVE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14876746 ↗