NA 242387Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705028825), received between Apr 18, 2023 and Sep 29, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934029 ↗
• MalfunctionSep 29, 2026Mechanical Jam

  This is report 1 of 2 of (b)(4).It was reported that during a Labral Repair procedure surgery, the GRYPHON FLEX BIOCRYL STRAIGHT device lever was not releasing. It was stuck and if the user tried to really push it, it would have broken. The user malleted the anchors back out which was not ideal. A spare device was used to complete the procedure. There was no delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934023 ↗
• MalfunctionApr 18, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE LIGHT GUIDE OLYM-ACMI_5.0MMX3.0M DEVICE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF TWO MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763628 ↗