BIOCRYL 231710Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705010608), received between Aug 10, 2018 and Dec 31, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2020Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN BRAZIL THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE SCREW DEVICE BROKE. IT WAS REPORTED THAT AN ALTERNATIVE PRODUCT WAS READILY AVAILABLE BUT THE PROCEDURE WAS NOT COMPLETED. IT WAS REPORTED THAT THERE WERE NO FRAGMENTS GENERATED AND NO SURGICAL INTERVENTION PLANNED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11101728 ↗
• MalfunctionSep 3, 2020Break; Break

  IT WAS REPORTED BY OUR TECHNICAL ASSISTANT VIA EMAIL, IN THE MOMENT OF THE SURGICAL PROCEDURE OF ANTERIOR CRUCIATE LIGAMENT (ACL), WHEN INTRODUCING THE BIOABSORBABLE SCREW, IT DID NOT SUPPORT, BREAKING A PART.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10487545 ↗
• MalfunctionJun 29, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY, IT WAS OBSERVED THAT THE ANCHOR BROKE UPON INSERTION. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10207018 ↗
• MalfunctionAug 10, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BIOCRYL INTERFERENCE SCREW, 8X23 MM DEVICE WAS BROKEN. THE BROKEN PIECE DIDN'T FALL INTO PATIENT. IT WAS REPORTED THAT THEY CHANGED TO A NEW BIOCRYL INTERFERENCE SCREW, 8X23 MM DEVICE TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7771823 ↗