GRYPHON 211036Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 10886705001484), received between Apr 3, 2018 and Sep 25, 2026 — classified as 99 malfunctions.

The most frequently reported specific device problem is “Break” (45 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 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Degraded; Illegible Information

  It was reported that during an unspecified surgical procedure, during drilling with the GRYPHON 2.4MM DRILL BIT device it was observed that the drill was not very sharp. It was reported that the surgeon continued with the same drill bit device, as there was no other option. It was reported that when the surgeon went to cut the suture with the CORDCUTTER device, the cutter device kept jamming, and the surgeon continued with the same device as there was no other option. It was reported that there was no delay in the procedure due to the event. It was reported that there was no harm to the patient or the user. All available information has been disclosed. No additional information has been provided.This is report 2 of 2 for (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896809 ↗
• MalfunctionJul 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059673 ↗
• MalfunctionJun 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE WHILE USING THE GRYPHON 2.4MM DRILL BIT DEVICE FOR THE FIRST ANCHOR THE POST THAT WAS LOADED IN THE CHUCK BROKE. THE SURGERY WAS DELAYED FOR FIVE MINUTES WHILE A SPARE DEVICE WAS RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169762 ↗
• MalfunctionOct 11, 2024Break; Break

  IT WAS REPORTED FROM JAPAN THAT DURING AN ARTHROSCOPIC BANKART REPAIR ON SHOULDER JOINT FOR RECURRENT DISLOCATION OF THE SHOULDER SURGICAL PROCEDURE THE GRYPHON 2.4MM DRILL BIT DEVICE WAS BEING USED ALONG WITH AN UNKNOWN INSERTION INSTRUMENT WHEN ATTEMPTING TO CREATE A HOLE FOR THE THIRD ANCHOR (GRYPHON BR) USING THE DRILL GUIDE AND DRILL, THE DRILL WAS BROKEN JUST BELOW THE DRILL STOPPER. NO RESIDUE WAS LEFT IN THE BODY BECAUSE THE OPERATION WAS PERFORMED OUTSIDE THE BODY. THE SURGERY PROCEEDED WITH ANOTHER LIKE DEVICE. 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 2 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427892 ↗
• MalfunctionSep 19, 2024Material Deformation; Material Deformation

  IT WAS REPORTED FROM JAPAN THAT DURING AN ARTHROSCOPIC BANKART REPAIR PROCEDURE, THE SURGEON ENCOUNTERED AN ISSUE WHILE ATTEMPTING TO DRILL THE FOURTH AND FINAL BONE HOLE FOR THE GRIFFON USING A FISHMOUTH GUIDE. THE RYPHON 2.4MM DRILL BIT DEVICE DID NOT ADVANCE AS EXPECTED, AND WHEN THE ASSISTANT SURGEON APPLIED ADDITIONAL FORCE, THE DRILL BENT AT THE JACOB'S CHUCK. AS A RESULT, THE USE OF THE GRIFFON WAS ABANDONED, AND ANOTHER SYSTEM WAS USED INSTEAD. THERE WAS THIRTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256971 ↗
• MalfunctionJul 15, 2024Break; Break

  IT WAS REPORTED, BY THE SALES REP IN (B)(6) ON 7/5/2024. THAT DURING, A JOINT LIP ARTHROPLASTY FOR LEFT SHOULDER PERFORMED. DRILLING WAS PERFORMED TO CREATE A BONE HOLE FOR INSERTING THE THIRD IMPLANT INTO NEAR THE ANTERIOR SUPERIOR EDGE OF THE GLENOID. THE GRYPHON 2.4MM DRILL BIT WAS BROKEN AT THE BORDER BETWEEN THE STOPPER AND THE SHAFT ON THE DRILL SIDE. AT THE SURGEON¿S DISCRETION, THE BROKEN SHAFT SIDE WAS INSTALLED TO THE POWER TOOL AND THE SURGEON DRILLED THROUGH THE GUIDE. THEN, THE IMPLANT WAS DEPLOYED. THE SURGEON CONFIRMED, THAT IT WAS FIXED WITHOUT PROBLEMS AND SUTURING WAS PERFORMED. THERE WAS NO SURGICAL DELAY. THE SURGEON WAS AWARE, THAT THE CAUSE WAS CLEARLY A MISDIRECTION OF DRILLING BY THE ASSISTANT SURGEON. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742620 ↗
• MalfunctionMar 7, 2024Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN ARTHROSCOPIC BANKART REPAIR (ABR) FOR A SHOULDER DISLOCATION PROCEDURE, IT WAS OBSERVED THAT THE GRYPHON 2.4MM DRILL BIT DEVICE WAS USED TO CREATE HOLES FOR AN ANCHOR INSERTION. HOWEVER, IT WAS DIFFICULT TO CREATE HOLES IN THE BONE. THE SURGEON INDICATED THAT THE BONE WAS HARD AT FIRST. THEN, IT WAS FOUND THAT THE DRILL BIT WAS NOT SHARP ENOUGH. THE DRILL BIT WAS USED TO CREATE FOUR HOLES. THE LAST HOLE WAS DRILLED A LITTLE WITH THE K-WIRE DEVICE, AND THE DRILL BIT WAS USED TO CREATE THE HOLE. 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 18856684 ↗
• MalfunctionFeb 8, 2024Break; Break

  IT WAS REPORTED BY THE THE SALES REP IN JAPAN THAT DURING A SHOULDER JOINT LIP ARTHROPLASTY FOR DISLOCATED FRACTURE OF SHOULDER JOINT ON (B)(6) 2024 THE GRYPHON 2.4MM DRILL BIT DEVICE WHEN DRILLING WAS PERFORMED TO INSERT THE THIRD ANCHOR, THE DRILL BIT IN QUESTION WAS BROKEN FROM THE DISK PORTION TO THE BASE. A BURR HOLE EQUAL TO THE DRILL LENGTH WAS CREATED WITH A K-WIRE, AND THEN THE THIRD ANCHOR WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WAS NO BROKEN PIECE IN THE PATIENT AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18666634 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN ARTHROSCOPIC BANKART REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE GRYPHON DRILL BIT DEVICE BROKE AND COULD NOT BE USED DURING SURGERY. 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 18442393 ↗
• MalfunctionDec 8, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC BANKART REPAIR (ABR) FOR SHOULDER INSTABILITY OF THE RIGHT SHOULDER PERFORMED ON (B)(6) 2023 IT WAS OBSERVED THAT WHEN THE SURGEON ATTACHED THE GRYPHON 2.4MM DRILL BIT DEVICE TO A POWER TOOL AND MADE A BURR HOLE, THE TIP OF THE DRILL BIT BROKE OFF WHEN THE SURGEON ATTEMPTED TO PULL THE DRILL BIT OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY BECAUSE THERE WAS NO USE OF THE DRILL BIT AFTER THAT. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THERE WAS NO SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291914 ↗
• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE GRYPHON 2.4MM DRILL BIT DEVICE, DURING DRILLING TO CREATE A BURR HOLE, THE BASE OF THE DRILL THAT CONNECTS TO THE DRILL AND THE TIP OF THE DRILL BIT BROKE OFF. IT WAS REPORTED THAT THE CAUSE SEEMED TO BE THAT THE DRILLING WAS PERFORMED AT AN UNREASONABLE ANGLE. THE BROKEN DRILL BIT WAS NOT RETAINED IN THE PATIENT'S BODY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 18057393 ↗
• MalfunctionSep 19, 2023Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC BANKART REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE GRYPHON DRILL BIT DEVICE WAS NOT SHARP WHICH MADE DRILLING DIFFICULT. 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. THIS COMPLAINT INVOLVES X (X) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774662 ↗
• MalfunctionSep 14, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ELBOW LIGAMENT REPAIR PROCEDURE ON (B)(6) 2023, A GRYPHON DRILL BIT DEVICE WAS USED. ACCORDING TO THE REPORT, DRILL BIT IN QUESTION COULD NOT BE REMOVED FROM THE GUIDE. IT WAS REPORTED THAT THE SURGEON MANAGED TO SEPARATE THE DRILL BIT AND THE GUIDE BUT THE DRILL BIT WAS DEFORMED AND COULD NOT PENETRATE TO THE END. IT WAS REPORTED THAT A K-WIRE WAS USED INSTEAD OF THE DRILL BIT. 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 17747475 ↗
• MalfunctionAug 31, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THROUGH IN-HOUSE DISTRIBUTION IN AUSTRALIA THAT DURING LOAN KIT INSPECTION, IT WAS OBSERVED THAT THE TIP ON THE GRYPHON DRILL BIT DEVICE WAS BENT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17664697 ↗
• MalfunctionAug 17, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE HARD STOP ON THE GRYPHON DRILL BIT DEVICE BECAME LOOSE. 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 17566984 ↗
• MalfunctionMar 21, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC LABIOPLASTY AND AN ARTHROSCOPIC BRISTOW PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE GRYPHON DRILL BIT DEVICE BROKE. ACCORDING TO THE REPORT, THE POSITION OF THE BURR HOLE WAS CHANGED, AND DRILLING WAS PERFORMED WITH A K-WIRE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584809 ↗
• MalfunctionMar 2, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHRODESIS PROCEDURE FOR RECURRENT DISLOCATION OF SHOULDER ON (B)(6) 2023, IT WAS OBSERVED THAT THE GRYPHON DRILL BIT DEVICE BROKE FROM ITS ROOT. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16468353 ↗
• MalfunctionFeb 7, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC BANKART REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE GRYPHON DRILL BIT DEVICE BROKE DURING DRILLING. THE BROKEN DRILL BIT WAS REMOVED COMPLETELY FROM THE PATIENT'S BODY. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313297 ↗
• MalfunctionDec 15, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A LABRAL REPAIR ON 11/18/2022, IT WAS OBSERVED THAT THE TIP ON THE GRYPHON DRILL BIT DEVICE WAS BENT AND COULD NOT BE USED. 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 15990486 ↗
• MalfunctionNov 1, 2022Degraded; Degraded

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE GRYPHON DRILL BIT DEVICE WAS VERY BLUNT. THE SAME 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 15710246 ↗
• MalfunctionOct 6, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ABR TREATING LABRUM SCAPULOHUMERAL INJURY ON (B)(6) 2022, IT WAS OBSERVED THAT THE GRYPHON DRILL BIT DEVICE BROKE AT THE CONNECTION PART TO A POWER TOOL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH OVER 30 MINUTES DELAY. THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15551280 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A COLLATERAL LIGAMENT SUTURING PROCEDURE IN THE ELBOW JOINT ON (B)(6) 2022, IT WAS OBSERVED THAT THE TAIL SECTION ON THE GRYPHON DRILL BIT DEVICE BROKE OFF. THE BROKEN FRAGMENT WAS REMOVED FROM THE LESION. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. 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 15412552 ↗
• MalfunctionSep 7, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE BACK OF THE DRILL BEHIND THE POSITIVE STOP ON THE GRYPHON DRILL BIT DEVICE SNAPPED OFF WHILE IN THE CHUCK WHILE DRILLING INTO THE SHOULDER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF ONE MINUTE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374282 ↗
• MalfunctionJul 11, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT THE GRYPHON DRILL BIT DEVICE WAS BENT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14981979 ↗
• MalfunctionJun 30, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GRYPHON DRILL BIT DEVICE WAS BENT. 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 14878986 ↗