GRYPHON 211037Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705001491), received between Jan 13, 2022 and Oct 15, 2025 — 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 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.

• MalfunctionOct 15, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SHAFT OF THE GRYPHON FISHMOUTH GUIDE DEVICE BROKE. IT WAS REPORTED THAT THE SHAFT OF THE GUIDE BENT OFF THE HANDLE. IT WAS REPORTED THAT THE SHAFT WAS SUCCESSFULLY RETRIEVED, AND ANOTHER GUIDE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, NOR SURGICAL DELAY REPORTED. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301195 ↗
• MalfunctionJan 13, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE RED HANDLE ON THE GRYPHON FISHMOUTH GUIDE DEVICE DISSOCIATED FROM SHAFT RESULTING IN BEING BROKEN IN TWO PIECES. ACCORDING TO THE REPORT, THE FAULT WAS A CLEAN BREAK AS IF THE RED HANDLE CAME OUT. 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 13254092 ↗