GRYPHON ORTHOCORD 210031Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886705019946), received between Aug 2, 2018 and May 16, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

5 other recalls cover devices cleared under the same FDA submission (K103712, K150209); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Break; Migration; Break; Migration

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY/LABRUM REPAIR PROCEDURE, THE ANCHOR ON THE GRYPHON PEEK ANCHOR W/OC DEVICE WAS FOUND TO BE EXPLANTED OR PULLED OUT. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE HAD BROKEN. THERE WAS A ONE-TO-TWO-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034776 ↗
• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE IT WAS OBSERVED THAT THE GRYPHON PEEK ANCHOR W/ORTHOCORD SUTURE WAS ELONGATED BY PULLING ONE SIDE OF THE SUTURE. THE SURGERY WAS ABLE TO BE COMPLETED WITH THE SAME ANCHOR, BUT THE SUTURE BROKE CAUSING A 2-3-MINUTE DELAY. NO PIECES WERE LEFT IN THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20776800 ↗
• MalfunctionMar 6, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE FOR A RIGHT ANKLE LIGAMENT INJURY ON (B)(6) 2024, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON PEEK ANCHOR W/OC DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. 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 18851833 ↗
• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING HIP SURGERY, IT WAS OBSERVED THAT THE GRYPHON PEEK ANCHOR W/ORTHOCORD DEVICE SUTURE WAS BROKEN OFF WHEN THE SUTURE WAS TIGHTENED. 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 18264869 ↗
• MalfunctionSep 15, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A LABRUM REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE GRYPHON PEEK ANCHOR W/ORTHOCORD DEVICE BROKE. 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 17756227 ↗
• MalfunctionDec 17, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE THAT DURING A LABRAL REPAIR SURGERY, IT WAS OBSERVED THAT THE GRYPHON PEEK ANCHOR W/OC DEVICE BROKE UPON INSERTION. IT WAS REPORTED THAT ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO 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: No Consequences Or Impact To Patient

  MAUDE report 9481839 ↗
• InjuryOct 31, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A HIP SURGERY PROCEDURE, IT WAS OBSERVED THAT THE SALES REP'S GRYPHON PEEK ANCHOR WITH ORTHOCORD BROKE IN HALF DURING INSERTION. THE SALES REP STATED THAT THE PROXIMAL END OF THE ANCHOR WAS REMOVED WITH A GRASPER, BUT THE DISTAL END WAS REMOVED USING A DRILL BIT. THE SALES REP STATED THAT THERE COULD BE DEBRIS LEFT IN THE PATIENT. THE SALES REP STATED THAT THE PATIENT HAD HARD BONE AND THE SURGEON WAS NOT OFF AXIS. THE CASE WAS COMPLETED USING TWO LIKE-ANCHORS IN NEW BONE HOLES ON EITHER SIDE OF THE FIRST BONE HOLE. THERE WAS A THREE MINUTE DELAY TO REMOVE THE ANCHOR. THE ANCHOR WAS DISCARDED BY THE CUSTOMER. THE STATUS OF THE PATIENT POST-SURGERY WAS NOT PROVIDED. IT WAS NOT REPORTED IF THERE WAS A 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: Foreign Body In Patient; Injury; Not Applicable

  MAUDE report 8025299 ↗
• MalfunctionAug 24, 2018Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING A HIP REPAIR THAT HER HIP KNOT MANIPULATOR WAS CUTTING SUTURE WHEN THE KNOT WAS BEING PUSHED DOWN. THE SALES REP REPORTED THAT THE DEVICE CUT THE SUTURE OF 2 OF THE ANCHORS, ONE CLOSE TO THE ANCHOR LEAVING NO SUTURE LEFT TO TIE IT AND THE OTHER 1/4 OF THE WAY DOWN THE SUTURE ALLOWING THE SURGEON TO USE THIS ANCHOR TO SECURE THE FIXATION. BOTH ANCHORS WERE LEFT SECURELY IN THE BONEHOLES. THE SURGEON COMPLETED THE PROCEDURE WITH THE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE THE LOT NUMBER FOR THE MANIPULATOR AT THIS TIME BUT WILL RETRIEVE IT FROM THE FACILITY. THE SALES REP REPORTED THAT THE CUSTOMER DOES NOT USE FIBERWIRE. SEE ALSO, MANUFACTURER REPORT NUMBER: 1221934-2018-52112.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7813943 ↗
• MalfunctionAug 24, 2018Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING A HIP REPAIR THAT HER HIP KNOT MANIPULATOR WAS CUTTING SUTURE WHEN THE KNOT WAS BEING PUSHED DOWN. THE SALES REP REPORTED THAT THE DEVICE CUT THE SUTURE OF 2 OF THE ANCHORS, ONE CLOSE TO THE ANCHOR LEAVING NO SUTURE LEFT TO TIE IT AND THE OTHER 1/4 OF THE WAY DOWN THE SUTURE ALLOWING THE SURGEON TO USE THIS ANCHOR TO SECURE THE FIXATION. BOTH ANCHORS WERE LEFT SECURELY IN THE BONEHOLES. THE SURGEON COMPLETED THE PROCEDURE WITH THE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE THE LOT NUMBER FOR THE MANIPULATOR AT THIS TIME BUT WILL RETRIEVE IT FROM THE FACILITY. THE SALES REP REPORTED THAT THE CUSTOMER DOES NOT USE FIBERWIRE. SEE ALSO, MANUFACTURER REPORT NUMBER: 1221934-2018-52113.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7813881 ↗
• MalfunctionAug 2, 2018Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING HIP SURGERY, IT WAS OBSERVED THAT THE GRYPHON PEEK ANCHOR W/ORTHOCORD DEVICES BROKE DURING INSERTION INTO GLENOID. IT WAS REPORTED THAT THIS EVENT HAPPENED TWICE IN THE SAME PROCEDURE. A REPLACEMENT ANCHOR WAS USED TO COMPLETE THE SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. 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 7742907 ↗
• MalfunctionAug 2, 2018Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING HIP SURGERY, IT WAS OBSERVED THAT THE GRYPHON PEEK ANCHOR W/ORTHOCORD DEVICES BROKE DURING INSERTION INTO GLENOID. IT WAS REPORTED THAT THIS EVENT HAPPENED TWICE IN THE SAME PROCEDURE. A REPLACEMENT ANCHOR WAS USED TO COMPLETE THE SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. 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 7742894 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103712, K150209. One submission often covers many models, so check the product and lot details in each record.

• Z-1678-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
• Z-1679-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
• Z-1680-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
• Z-1681-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
• Z-1677-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724