BIOSCREW C8026Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854016671), received between Oct 4, 2018 and Dec 18, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2019Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT C8026 DEVICE WAS BEING USED ON DURING AN ACL PROCEDURE ON (B)(6) 2019 WHEN THE GUIDEWIRE BROKE IN THE GRAFT. THE DEVICE FRAGMENTS WERE REMOVED. THERE WAS NO REPORT OF INJURY TO THE PATIENT OR THE USER. THERE WAS NO REPORT OF 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 Consequences Or Impact To Patient

  MAUDE report 9488411 ↗
• MalfunctionOct 4, 2018Break; Break

  THE CUSTOMER REPORTED THAT THE 5129491, BIOSCREW HYPERFLEX GUIDEWIRE, BROKE DURING SURGERY. THIS CAUSED A 2 HOUR DELAY, THERE WAS NO REPORTED PATIENT INJURY, HOWEVER, THE EXTENDED TIME UNDER ANESTHESIA DOES IMPACT THE PATIENT. FURTHER ATTEMPTS WE MADE TO GET ADDITIONAL INFORMATION BUT NONE WAS PROVIDED. THIS REPORT IS BEING RAISED ON THE BASIS OF DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7933649 ↗