BIOCRYL 231715Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705010615), received between Feb 21, 2019 and Oct 28, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 18, 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.

• MalfunctionOct 28, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN CHINA THAT DURING A LIGAMENT REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANCHOR ON THE BIOCRYL INTSCR 8X30MM DEVICE WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12713622 ↗
• MalfunctionFeb 21, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE SCREW BROKE. THE AFFILIATE DID NOT REPORT ANY PATIENT HARM. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE ON 02/19/19 REPORTING THERE WAS NO SURGICAL DELAY AND THE CASE WAS COMPLETED BY USING A DIFFERENT SCREW WHICH WAS READILY AVAILABLE. IT WAS ALSO REPORTED THAT THE FAILURE WAS IDENTIFIED DURING THE PROCEDURE AND NO SURGICAL INTERVENTION WAS PLANNED. THE AFFILIATE ALSO STATED THAT THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358361 ↗