GRYPHON Flex 208956Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886705032433), received between Jun 19, 2024 and Sep 30, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Jam

  It was reported that during an unspecified procedure, it was very difficult to push down the lever of the GRYPHON FLEX. The doctor completed the procedure implant successfully but with difficulty. 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 50944567 ↗
• MalfunctionNov 6, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE, IT WAS OBSERVED THAT THE LEVER ON THE GRYPHON FLEX BIOCRYL STRAIGHT DEVICE COULD NOT BE ENGAGED; AND THAT THE ANCHOR WOULD PULL OUT WHEN REMOVING THE INSERTER. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE GRAY LEVER WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620563 ↗
• MalfunctionOct 29, 2024Crack; Appropriate Device Problem Term/Code Not Available; Crack; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE AFFILIATE THAT DURING SERVICE AND REPAIR, IT WAS DETERMINED THAT THE GRYPHON FLEX BIOCRYL STRAIGHT DEVICE HAD AN UNDETERMINED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE TIP WAS BROKEN. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559470 ↗
• MalfunctionOct 24, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE, IT WAS OBSERVED THAT THE LEVER ON THE GRYPHON FLEX BIOCRYL STRAIGHT DEVICE COULD NOT BE ENGAGED; AND THAT THE ANCHOR WOULD PULL OUT WHEN REMOVING THE INSERTER. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE GRAY LEVER WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20527247 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE FIVE (X5) GRYPHON FLEX BIOCRYL STRAIGHT DEVICES AND ONE GRYPHON BR W/ PROKNOT DEVICE HAD 4 ANCHORS BRAKE DURING INSERTION AND 2 ANCHORS THE LEVER COULD NOT BE ENGAGED, THE ANCHORS PULLED OUT WHEN REMOVING THE INSERTER. ONE OF THE DEVICES WAS BROKEN. ALTERNATIVE DEVICES WERE USED TO COMPLETE THE REPAIR. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20150116 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE FIVE (X5) GRYPHON FLEX BIOCRYL STRAIGHT DEVICES AND ONE GRYPHON BR W/ PROKNOT DEVICE HAD 4 ANCHORS BRAKE DURING INSERTION AND 2 ANCHORS THE LEVER COULD NOT BE ENGAGED, THE ANCHORS PULLED OUT WHEN REMOVING THE INSERTER. ONE OF THE DEVICES WAS BROKEN. ALTERNATIVE DEVICES WERE USED TO COMPLETE THE REPAIR. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20149988 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE FIVE (X5) GRYPHON FLEX BIOCRYL STRAIGHT DEVICES AND ONE GRYPHON BR W/ PROKNOT DEVICE HAD 4 ANCHORS BRAKE DURING INSERTION AND 2 ANCHORS THE LEVER COULD NOT BE ENGAGED, THE ANCHORS PULLED OUT WHEN REMOVING THE INSERTER. ONE OF THE DEVICES WAS BROKEN. ALTERNATIVE DEVICES WERE USED TO COMPLETE THE REPAIR. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20149738 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE FIVE (X5) GRYPHON FLEX BIOCRYL STRAIGHT DEVICES AND ONE GRYPHON BR W/ PROKNOT DEVICE HAD 4 ANCHORS BRAKE DURING INSERTION AND 2 ANCHORS THE LEVER COULD NOT BE ENGAGED, THE ANCHORS PULLED OUT WHEN REMOVING THE INSERTER. ONE OF THE DEVICES WAS BROKEN. ALTERNATIVE DEVICES WERE USED TO COMPLETE THE REPAIR. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20149732 ↗
• MalfunctionSep 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGICAL PROCEDURE THE GRYPHON FLEX BIOCRYL STRAIGHT DEVICE EXTRACTION LEVER WOULD NOT DEPLOY AND SURGEON HAD TO BACK SLAP THE INSERTER OUT. 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 20148281 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER POSTERIOR LABRAL SURGICAL PROCEDURE ON (B)(6) 2024 THE GRYPHON FLEX BIOCRYL STRAIGHT DEVICE STRIKE CAP WAS NOT ADVANCED. THERE WAS A FAILURE TO EXTRACT INSERTER HANDLE FROM IMPLANT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF THE SAME EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026784 ↗
• MalfunctionAug 21, 2024Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER POSTERIOR LABRAL SURGICAL PROCEDURE ON (B)(6) 2024 THE GRYPHON FLEX BIOCRYL STRAIGHT DEVICE STRIKE CAP WAS NOT ADVANCED. THERE WAS A FAILURE TO EXTRACT INSERTER HANDLE FROM IMPLANT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015361 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING POSTERIOR LABRAL REPAIR PROCEDURE ON (B)(6) 2024 THE GRYPHON FLEX BIOCRYL STRAIGHT DEVICE HAD NITNOL TIP SPLINTERING IN HALF BEFORE INSERTING ANCHOR INTO PILOT HOLE ON GLENOID. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A THREE MINUTE 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 19927115 ↗
• MalfunctionJul 17, 2024Break; Device-Device Incompatibility; Mechanical Jam; Break; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING A LABRAL REPAIR SURGICAL PROCEDURE, THE GRYPHON FLEX BIOCRYL STRAIGHT INSERTION STUCK UPON INSERTION OF ANCHOR AND TRIED TO RELEASE WITH LEVER WAS BROKEN. IT WAS REPORTED THAT THE BUTTON WAS HELD DOWN ON TOP OF THE ANCHOR AND LOCK HANDLE WITH MALLET AND INSERTION CAME OFF. THROWN AWAY. 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 19759226 ↗
• MalfunctionJun 19, 2024Device-Device Incompatibility; Difficult to Advance; Material Deformation; Device-Device Incompatibility; Difficult to Advance; Material Deformation

  THIS IS REPORT 1 OF 2 FOR (B)(4) IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE, IT WAS DISCOVERED THAT TWO UNKNOWN ANCHOR DEVICES HAD STRAIGHT BUTTON ON TOP OF THE ANCHOR THAT WAS NOT ENGAGED PROPERLY. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567589 ↗
• MalfunctionJun 19, 2024Device-Device Incompatibility; Difficult to Advance; Material Deformation; Device-Device Incompatibility; Difficult to Advance; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE, IT WAS DISCOVERED THAT TWO UNKNOWN ANCHOR DEVICES HAD STRAIGHT BUTTON ON TOP OF THE ANCHOR THAT WAS NOT ENGAGED PROPERLY. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567588 ↗