BioScrew HyperFlex C8027DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854041727), received between Mar 25, 2024 and Mar 25, 2024 — 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.

• MalfunctionMar 25, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE C8027D BIOSCREW HYPERFLEX GUIDEWIRE NITINOL 18.5 IN STER WAS BEING USED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2024 DATE WHEN IT WAS REPORTED ¿THE ACL GUIDE WIRE WAS IN THE TIBIA, SCREW WAS INSERTED, THE GUIDE WIRE WAS STUCK, UPON PULLING THE TIP BROKE AND HAD TO BE RETRIEVED. FLUOROSCOPY HAD TO BE BROUGHT IN TO CERTIFY THE FRAGMENT WAS REMOVED.¿. IT WAS ALSO REPORTED ¿THEY BACKED OUT THE SCREW AND GRABBED THE FRAGMENT WITH A SNAP.¿ THE PROCEDURE WAS COMPLETED WITH A 10-MINUTE DELAY. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿UNHARMED, WILL BE DISCHARGED AS NORMAL.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. 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 18967568 ↗