GRYPHON 211601Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886705025527), received between Aug 16, 2018 and Feb 28, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Degraded” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE GRYPHON HARD BONE DRILL SEEMED TO BE BLUNT. IT WAS REPORTED THAT THE SURGEON WAS HAVING TROUBLE GETTING THE DEVICE TO DRILL WITHOUT A LOT OF PRESSURE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21496596 ↗
• MalfunctionApr 19, 2023Degraded; Degraded

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE GRYPHON HARD BONE DRILL DEVICE WAS 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 16772257 ↗
• MalfunctionFeb 28, 2022Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GRYPHON HARD BONE DRILL DEVICE WAS TOO DULL. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13624630 ↗
• MalfunctionFeb 28, 2022Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GRYPHON HARD BONE DRILL DEVICE WAS TOO DULL. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13624613 ↗
• MalfunctionFeb 28, 2022Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GRYPHON HARD BONE DRILL DEVICE WAS TOO DULL. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13624598 ↗
• MalfunctionOct 20, 2021Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE GRYPHON HARD BONE DRILL DEVICE WAS BLUNT. 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 12667281 ↗
• MalfunctionOct 20, 2021Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE GRYPHON HARD BONE DRILL DEVICE WAS BLUNT. 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 12667226 ↗
• MalfunctionAug 6, 2021Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE GRYPHON HARD BONE DRILL DEVICE WAS BLUNT. THE SAME 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 12289187 ↗
• MalfunctionApr 21, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT PRE-OPERATIVELY TO A TENDON REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT A GRYPHON HARD BONE DRILL DEVICE WAS TOO DULL. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699709 ↗
• MalfunctionJan 15, 2021Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO A LABRAL REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE DRILL BIT WAS BENT. 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 11179934 ↗
• MalfunctionJan 15, 2021Degraded

  IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO A BICEPS TENODESIS PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE DRILL BIT DEVICE WAS TOO DULL/WORN TO WORK. 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 11179903 ↗
• MalfunctionJan 15, 2021Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT A GRYPHON HARD BONE DRILL WAS TOO DULL AND OVERUSED TO WORK PROPERLY. THERE WAS NO SURGICAL DELAY REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11178765 ↗
• MalfunctionJan 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REPL THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT A GRYPHON HARD BONE DRILL DEVICE WAS BENT. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11149266 ↗
• MalfunctionAug 17, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT PRE-OPERATIVELY TO A BANKART REPAIR, A GRYPHON HARD BONE DRILL BIT WAS BENT. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10417452 ↗
• MalfunctionSep 5, 2019Failure to Cut; Failure to Cut

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING A SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2019 THE ANCHOR FRACTURED SLIGHTLY DURING INSERTION AND GRYPHON HARD BONE DRILL WAS FOUND TO BE BLUNT. SURGEON WAS ABLE TO REMOVE ALL FRAGMENTS OF THE ANCHOR WITH NO ISSUE. THERE WAS INCREASED SURGICAL TIME OF 30 SECONDS. THERE WAS NO ADVERSE CONSEQUENCE TO PATIENT. IT WAS LATER REPORTED THAT THE CASE WAS COMPLETED WITH ANOTHER DRILL. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8965806 ↗
• MalfunctionJul 30, 2019Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  IT WAS REPORTED BY THE AFFILIATE VAI E-MAIL THAT THE GRYPHON HARD BONE DRILL BIT WAS BLUNT DURING THE SHOULDER STABILIZATION PROCEDURE. SURGEON WAS ABLE TO CONTINUE WITH THE SURGERY ALTHOUGH THERE WAS SOME DIFFICULTY PUSHING THROUGH THE CORTEX. THERE WAS NO ISSUE WITH ANCHOR INSERTION AND NO ADVERSE EFFECTS UPON THE PATIENT. THE DRILL BIT WAS DISPOSED OFF BY THE HOSPITAL. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTING A SURGICAL DELAY DID NOT OCCUR DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8842191 ↗
• MalfunctionJan 18, 2019Fracture; Fracture

  IT WAS REPORTED BY THE SALES REP THAT DURING A HIP SCOPE PROCEDURE THEIR GRYPHON HARD BONE DRILL BIT WAS DROPPED ON THE FLOOR AND THE TIP OF THE DEVICE BROKE. THE SALES REP STATED THAT THE DEVICE BROKE OUTSIDE THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS LESS THAN A YEAR OLD AND HAS SEEN HEAVY USE IN THE FIELD. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 8260147 ↗
• MalfunctionJan 17, 2019Fracture; Fracture

  THE SALES REP REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DISTAL TIP OF THE CUSTOMER¿S GRYPHON DRILL BIT BROKE OFF THE DEVICE WHEN IT WAS ACCIDENTALLY DROPPED ONTO THE FLOOR. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 8257554 ↗
• MalfunctionJan 14, 2019Fracture; Fracture

  THE SALES REP REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE HIP, IT WAS OBSERVED THAT THE DISTAL TIP OF HIS GRYPHON HARD BONE DRILL BIT BROKE WHEN THE SCRUB TECH DROPPED THE DEVICE ON THE FLOOR. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE THE LOT NUMBER FOR THE DEVICE BUT REPORTED THAT IT WAS OVER 2 YEARS OLD AND HAD BEEN HEAVILY USED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 8245930 ↗
• MalfunctionDec 28, 2018Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE CUSTOMER'S GRYPHON HARD BONE DRILL WAS USED AND REMOVED FROM THE PATIENT BECAUSE IT WAS DULL. THE CUSTOMER'S SECOND GRYPHON HARD BONE DRILL WAS ALSO DULL, BUT WAS USED TO COMPLETE THE CASE BECAUSE THERE WERE NO ALTERNATIVE DEVICES. THERE WAS NO PATIENT HARM OR DELAY. THE SALES REP STATED THAT THE PATIENT HAD HARD BONE. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR EITHER DEVICE. THE DEVICES ARE BEING RETURNED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 8202560 ↗
• MalfunctionDec 28, 2018Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE CUSTOMER'S GRYPHON HARD BONE DRILL WAS USED AND REMOVED FROM THE PATIENT BECAUSE IT WAS DULL. THE CUSTOMER'S SECOND GRYPHON HARD BONE DRILL WAS ALSO DULL, BUT WAS USED TO COMPLETE THE CASE BECAUSE THERE WERE NO ALTERNATIVE DEVICES. THERE WAS NO PATIENT HARM OR DELAY. THE SALES REP STATED THAT THE PATIENT HAD HARD BONE. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR EITHER DEVICE. THE DEVICES ARE BEING RETURNED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 8202558 ↗
• MalfunctionOct 4, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT FOLLOWING A SHOULDER REPAIR PROCEDURE THE SALES REP'S GRYPHON HARD BONE DRILL WAS DULL. THE SALES REP STATED THE PATIENT HAD A HARD BONE DENSITY. THE CASE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT HARM OR DELAYS. THE SALES REP WAS UNABLE TO PROVIDE A LOT NUMBER. THE DEVICE WAS DISCARDED IN THE SHARPS CONTAINER BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 7935284 ↗
• MalfunctionSep 7, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A HIP PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THEIR GRYPHON HARD BONE DRILL BIT BROKE OFF WHEN THE SCRUB TECH WAS PUTTING THE DEVICE INTO THE TRAY. THE SALES REP STATED THAT THE DEVICE DID NOT BREAK IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS OVER A YEAR OLD AND HAS SEEN HEAVY USE IN THE FIELD. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 7857093 ↗
• MalfunctionAug 16, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER PROCEDURE THEIR GRYPHON HARD BONE DRILL BIT FELL ON THE FLOOR RESULTING IN THE DISTAL TIP OF THE DEVICE TO CHIP. THE SALES REP STATED THAT THEY WERE UNABLE TO USE THE DEVICE DUE TO THE TIP CHIPPING. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES BUT THERE WAS A TWO MINUTE DELAY TO SWAP OUT THE DEVICE. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 7788241 ↗