GRYPHONRecalls & reported problems across all models

We found 2 models of GRYPHON by Depuy Mitek, LLC in the FDA's device registry (GUDID). Together they are named in 61 adverse event reports in the FDA's MAUDE database, received between Aug 11, 2018 and Mar 17, 2026 — classified as 61 malfunctions.

The most frequently reported specific device problem is “Break” (35 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GRYPHON problems

GRYPHON models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GRYPHON 210824

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  31 reports
• GRYPHON 210826

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  30 reports

Recent GRYPHON adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE GRYPHON SLOTTED FISHMOUTH GDE DEVICE HANDLE WAS DISCONNECTED FROM THE SHAFT. IT IS UNKNOWN IF ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619569 ↗
• MalfunctionSep 8, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE GRYPHON SLOTTED SAWTOOTH GDE DEVICE WAS BROKEN WHILE USING IT. 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 22990611 ↗
• MalfunctionJun 13, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE GRYPHON SLOTTED FISHMOUTH GDE DEVICE DISTAL PART OF THE GRYPHON DRILL GUIDE IS BROKEN AND THE JAW IS BENT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201343 ↗
• MalfunctionSep 16, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE GRYPHON SLOTTED FISHMOUTH DEVICE WAS IN TWO PIECES. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226362 ↗
• MalfunctionAug 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LABRUM REPAIR PROCEDURE, IT WAS OBSERVED THAT THE SHAFT ON THE GRYPHON SLOTTED FISHMOUTH GUIDE DEVICE WAS DISCONNECTED FROM ITS HANDLE. THEY USED A PEEL PACKED BACK UP INSTRUMENTATION TO COMPLETE THE CASE. 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 20045839 ↗
• MalfunctionAug 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 WHILE USING THE GRYPHON SLOTTED SAWTOOTH GDE DEVICE WHEN REMOVING THE DRILL GUIDE AFTER IMPLANTING THE GYPHON ANCHOR THE DRILL GUIDE HANDLE CAME APART FROM THE DRILL GUIDE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937484 ↗
• MalfunctionJun 20, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A LABRAL REPAIR SHOULDER ARTHROSCOPY SURGICAL PROCEDURE ON AN UNKNOWN DATE, THE GRYPHON DEVICE HAD SHAFT AND HANDLE DISENGAGED INTO TWO PIECES. 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 19574746 ↗
• MalfunctionFeb 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE SHAFT PART ON THE GRYPHON SLOTTED SAWTOOTH GDE DEVICE CAME OFF WHEN IT WAS LIFTED FOR USE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 18763382 ↗
• MalfunctionJul 10, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GRYPHON SLOTTED FISHMOUTH GUIDE DEVICE BROKE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17289722 ↗
• MalfunctionJul 10, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GRYPHON SLOTTED SAWTOOTH GUIDE DEVICE WAS SPLIT WHEN UNCOVERING. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17289710 ↗
• MalfunctionJul 6, 2023Break; Break

  GRYPHON GUIDE (210826) IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE GRYPHON SLOTTED FISHMOUTH GUIDE DEVICE BROKE IN HALF. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. 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 17270361 ↗
• MalfunctionJul 6, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GRYPHON SLOTTED FISHMOUTH GUIDE DEVICE BROKE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17270130 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A LABRUM REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE GRYPHON SLOTTED FISHMOUTH GUIDE WAS BENT AND EVENTUALLY BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16878992 ↗
• MalfunctionFeb 7, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN COLOMBIA THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TUBE WAS SEPARATED FROM THE HANDLE ON THE GRYPHON SLOTTED SAWTOOTH GUIDE DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD BEEN HEAVILY USED AS STRIATIONS ON THE METAL SURFACE OF THE HANDLE DISTAL FROM THE SHAFT CONNECTION POINT AND THE EDGES WERE BENT. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 16311443 ↗
• MalfunctionJan 3, 2023Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT THE GRYPHON SLOTTED SAWTOOTH GUIDE DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SHAFT WAS SEPARATED FROM THE HANDLE DUE TO WELDING DETACHMENT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091581 ↗

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