GRYPHON 210824Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10886705024063), received between Dec 10, 2018 and Sep 8, 2025 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 31 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionDec 20, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE GRYPHON SLOTTED SAWTOOTH GUIDE DEVICE BROKE IN HALF. 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 16018123 ↗
• MalfunctionOct 31, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE, THE GRYPHON SLOTTED SAWTOOTH GUIDE DEVICE BROKE IN HALF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700987 ↗
• MalfunctionSep 22, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING INSPECTION ON (B)(6) 2022, IT WAS OBSERVED THAT THE GRYPHON SLOTTED SAWTOOTH GUIDE DEVICE SHAFT HAS BROKEN AWAY FROM THE HANDLE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463023 ↗
• MalfunctionSep 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN COLOMBIA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE GRYPHON SLOTTED SAWTOOTH GUIDE DEVICE CAME LOOSE FROM THE HANDLE. 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 15382231 ↗
• MalfunctionJul 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY SALES REP THAT DURING A LABRUM REPAIR ON (B)(6) 2022, IT WAS OBSERVED THAT THE GRYPHON SLOTTED SAWTOOTH GUIDE DEVICE HAD SEPARATION OF THE SHAFT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15007300 ↗
• MalfunctionMay 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT BEFORE AN SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE METAL PIECE ON THE GRYPHON SLOTTED SAWTOOTH GUIDE DEVICE CAME OUT FROM THE HANDLE. 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 11814850 ↗
• MalfunctionApr 27, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A LABRAL REPAIR THE GRYPHON SLOTTED SAWTOOTH GUIDE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE AVAILABILITY IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11733713 ↗
• MalfunctionApr 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE BONENAIL GUIDEWIRE DEVICE DISASSEMBLED WHEN IT WAS REMOVED THAT ONLY THE HANDLE CAME OUT AND THE TIP REMAINED INSIDE THE CANNULA. THE PROCEDURE WAS COMPLETED BY PASSING THE OTHER RED GUIDE THAT CAME IN WITH THE DEVICE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11634011 ↗
• MalfunctionJan 22, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON 1/6/2021, IT WAS OBSERVED THAT THE GRYPHON SLOTTED SAWTOOTH GUIDE DEVICE BROKE APART. THERE WERE NO FRAGMENTS GENERATED. 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 11214795 ↗
• MalfunctionSep 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THE GRYPHON BR W/ PROKNOT. THE WELDING SEAM IS BROKEN AND THE SHAFT NOW FALLS OFF THE HANDLE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE DEFECT WAS NOTICED DURING THE LOAN SET INSPECTION AT THE SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10525372 ↗
• MalfunctionSep 3, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER ARTHROSCOPY THE SURGEON WHEN TAKING OUT THE DRILL THE TIP OF THE GRYPHON SLOTTED SAWTOOTH GUIDE CAME OUT FROM THE HANDLE. NO FRAGMENTS REMAINED IN THE PATIENT´S BODY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10490311 ↗
• MalfunctionAug 24, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA ONLINE COMPLAINT SUBMISSION TOOL THAT DURING A SHOULDER SURGERY THE GRYPHON SLOTTED SAWTOOTH GDE DRILL GUIDE BROKE. THE AFFILIATE IS AWAITING, AWAITING FURTHER DETAILS FROM ACCOUNT. ADDITIONAL DETAILS PROVIDED BY THE AFFILIATE REPORTED NO FRAGMENTS WERE GENERATED AND A 10 MINUTE SURGICAL DELAY OCCURRED. IT WAS REPORTED THE PATIENT DID NOT SUFFER COMPLICATIONS DUE TO THE SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THE AFFILIATE REPORTED THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 10442868 ↗
• MalfunctionMay 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REP REPORTED VIA PHONE CALL THAT THE CUSTOMER'S GRYPHON PRO KNOT SAW TOOTH DRILL GUIDE FAILED DURING A LABRUM PROCEDURE DUE TO THE DEVICE BEING OLD, DULL AND WORN. THE CASE WAS COMPLETED USING ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR TIME DELAY. THE SALES REP WAS NOT PRESENT FOR THE CASE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10061018 ↗
• MalfunctionMar 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY AFFILIATE VIA PERSONAL INTERACTION THAT THE GRYPHON SLOTTED SAWTOOTH GDE SHAFT CAME OFF THE HANDLE WHILE THE SURGEON WAS USING IT. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9886641 ↗
• MalfunctionMar 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE THE SHAFT OF THE GRYPHON SLOTTED SAWTOOTH GUIDE CAME OFF FROM THE HANDLE BEFORE USING IT IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9867003 ↗
• MalfunctionMar 17, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT TWO OF THE GRYPHON SLOTTED SAWTOOTH GUIDE WERE BREAKING AT THE SPOT WHEEL. ONE OUT OF TWO DEVICES IS AVAILABLE TO BE RETURNED FOR EVALUATION. NO PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844601 ↗
• MalfunctionMar 17, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT TWO OF THE GRYPHON SLOTTED SAWTOOTH GUIDE WERE BREAKING AT THE SPOT WHEEL. ONE OUT OF TWO DEVICES IS AVAILABLE TO BE RETURNED FOR EVALUATION. NO PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844586 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE THAT THE GRYPHON SLOTTED SAWTOOTH GUIDE BROKE AT THE HANDLE AND SHAFT WHEN THE SURGEON TRIED TO IMPLANT THE ANCHOR INTO THE PATIENT'S BODY DURING THE SURGERY. BREAKAGE OCCURRED OUTSIDE THE PATIENT'S BODY. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE ANCHOR, THE PRODUCT CODE AND LOT NUMBER WERE UNKNOWN. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO INFORMATION OF SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125346 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA CST THAT FOLLOWING AN UNKNOWN PROCEDURE THE GRYPHON SLOTTED SAWTOOTH GUIDE BROKE WHILE CLEANING DURING SPD. IT¿S BROKE WHERE THE GUIDE ATTACHES TO THE HANDLE. THERE WAS NO PATIENT HARM. THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125165 ↗