GRYPHON 210826Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886705024131), received between Aug 11, 2018 and Mar 17, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 25 most recent of 30 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• MalfunctionApr 7, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A LABRUM REPAIR PROCEDURE OF THE SHOULDER ON (B)(6) 2022, IT WAS OBSERVED THAT THE SHAFT ON THE GRYPHON 2.4MM DRILL BEI LONG BROKE OFF. THERE WERE NO SURGICAL DELAY NOR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14046824 ↗
• MalfunctionMar 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE HANDLE ATTACHMENT ON THE GRYPHON SLOTTED FISHMOUTH GDE DEVICE CAME APART. 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 13711682 ↗
• MalfunctionSep 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING A CAPSULORRHAPHY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE GRYPHON SLOTTED FISHMOUTH GDE DEVICE DISASSEMBLED IN THE MIDDLE OF THE SURGERY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453234 ↗
• MalfunctionJun 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE HANDLE ON THE GRYPHON SLOTTED FISHMOUTH GUIDE DEVICE GOT SEPARATED FROM THE INSERTER SHAFT. 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 11975729 ↗
• MalfunctionJun 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE HANDLE ON THE GRYPHON SLOTTED FISHMOUTH GUIDE DEVICE GOT SEPARATED FROM THE INSERTER SHAFT. 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 11975705 ↗
• MalfunctionJun 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE GUIDE ON THE GRYPHON SLOTTED FISHMOUTH GDE DEVICE DISARMED WHEN THE GUIDE WAS REMOVED FROM THE ARTHROSCOPY CANNULA. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE BLUE GUIDE THAT WENT ON THE INSTRUMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968463 ↗
• MalfunctionMar 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SLEEVE ON THE DRILL GUIDE DEVICE COME APART FROM HANDLE. BOTH FRAGMENTS RECOVERED AND 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 11455346 ↗
• MalfunctionMar 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE DRILL SLEEVE HAD PULLED AWAY FROM THE HANDLE ON THE GRYPHON SLOTTED FISHMOUTH GUIDE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A FIVE MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445041 ↗
• MalfunctionMar 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER ARTHROSCOPY WITH A LABRUM REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE HANDLE ON THE GRYPHON SLOTTED FISHMOUTH GDE DEVICE SEPARATED FROM ITS SHAFT WHILE DRILLING. THERE WAS NO DELAY IN THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399756 ↗
• MalfunctionOct 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING CLEANING PROCESS THE GRYPHON SLOTTED FISHMOUTH GUIDE CAME OFF OF THE INSERTER. NO PATIENT INVOLVEMENT. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10707620 ↗
• MalfunctionOct 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A LABRAL REPAIR PROCEDURE THE SHAFT OF THE GRYPHON SLOTTED FISHMOUTH GUIDE GOT SEPARATED FROM THE HANDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES REPORTED. 5 MINUTES DELAY. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 10622277 ↗
• MalfunctionSep 23, 2020Break; Break

  IT WAS REPORTED BY SALES REP VIA EMAIL THAT DURING A LABRAL REPAIR A GRYPHON SLOTTED FISHMOUTH GUIDE BROKE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO FRAGMENTS WERE GENERATED. DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10577410 ↗
• MalfunctionAug 11, 2020Break; Break

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT WHILE PERFORMING A SHOULDER STABILIZATION A GRYPHON SLOTTED FISHMOUTH GUIDE DISSOCIATED INTO 2 LARGE PIECES. IT WAS BROKEN AT THE JOIN BETWEEN THE GUIDE SHAFT AND GUIDE HANDLE. THEY WERE ABLE TO RECOVER BOTH PIECES. THERE WAS A SURGICAL DELAY OF 1 MINUTE TO GET ANOTHER DRILL GUIDE TO COMPLETE PROCEDURE. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Not Applicable

  MAUDE report 10392240 ↗
• MalfunctionMar 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE HANDLE ON THE CUSTOMER'S GRYPHON SLOTTED FISHMOUTH GUIDE SEPARATED FROM THE HANDLE. THERE WAS NO DEBRIS IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9876055 ↗
• MalfunctionSep 27, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMER'S GRYPHON SLOTTED FISHMOUTH GUIDE BROKE WHERE THE HANDLE ATTACHES TO THE GUIDE. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM. THE SALES REP STATED THERE WAS A MINOR TIME DELAY TO SWITCH TO THE NEW DEVICE, BUT DID NOT KNOW HOW LONG. THE SALES REP WAS NOT PRESENT AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 9128712 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT A LOAN KIT TECHNICIAN DISCOVERED THAT THE SLOTTED SHAFT WAS BROKEN AWAY FROM THE HANDLE DURING A LOAN KIT INSPECTION. THE DEVICE HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. THE AFFILIATE REPORTS THAT NO PATIENT INFORMATION IS AVAILABLE. THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9124791 ↗