GRYPHON Flex 208955Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705032488), received between Jul 11, 2024 and Sep 25, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Product Quality Problem; Use of Device Problem

  It was reported that during a right shoulder Bankart repair shoulder procedure, it was observed that the threader tab of the GRYPHON FLEX PEEK STRAIGHT device was missing from the implant. It was reported that a threader tab from a previous implant was used to load the suture onto the implant. During visual inspection of a photo that was received found the inserter outside of the packing without the kite assembled. It was reported that there was no delay in the procedure due to the event. There were no adverse consequences to the patient. No additional information could be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896172 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE GRYPHON FLEX PEEK STRAIGHT DEVICE DURING IMPLANT INSERTION PROCEDURE THE FLEXIBLE NITINOL TIP WAS BROKEN. PATIENT WAS NOT HARMED AND MINIMAL TIME WAS ADDED TO THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148247 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY SALES REP VIA EMAIL THAT DURING LABRAL REPAIR PROCEDURE ON (B)(6) 2024 USING THE GRYPHON FLEX PEEK STRAIGHT DEVICE AFTER TENSIONING AND INSERTING ANCHOR, THE LEVER WOULD NOT RELEASE IN ORDER TO REMOVE INSERTER. ACCRORDING TO THE REPORTER THE SURGEON HAD TO TWIST THE INSERTER TO REMOVE AND WAS NEVER ABLE TO RELEASE THE LEVEL, IT WAS VERY DIFFICULT TO REMOVE THE INSERTER AND A MALLET WAS USED TO REMOVE THE INSERTER. THE SURGEON WAS ABLE TO REMOVE INSERTER AND COMPLETE THE CASE WITHOUT ANY COMPLICATION. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. DEVICE WAS DISPOSED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720148 ↗
• MalfunctionJul 11, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP THAT DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2024 IT WAS DISCOVERED THAT WHILE USING THE GRYPHON FLEX PEEK STRAIGHT, AFTER TENSIONING AND INSERTING ANCHOR, THE LEVER WOULD NOT RELEASE IN ORDER TO REMOVE INSERTER. THE SURGEON CONTINUE TO TRY TO RELEASE THE LEVER BUT IT BROKE OFF THE INSERTER HANDLE. THE SURGEON WAS ABLE TO REMOVE INSERTER AND COMPLETE THE CASE WITHOUT ANY COMPLICATION. THERE WAS NOT ADVERSE COMPLICATION TO THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19718054 ↗