GRYPHON ORTHOCORD 210812Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886705001262), received between Apr 30, 2018 and May 12, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Break” (17 reports).

6 other recalls cover devices cleared under the same FDA submission (K073412, 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE GRYPHON T BR ANCHOR W/OC DEVICE USED FOR LABRUM SUTURING BROKE OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. 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 25148504 ↗
• MalfunctionSep 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A ANKLE JOINT LIGAMENT REPAIR SURGERY, THE GRYPHON T BR ANCHOR W/OC WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066825 ↗
• MalfunctionMay 2, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING A GLENOID LIP OF SHOULDER JOINT REPAIR PROCEDURE, IT WAS OBSERVED THAT THE DEVICE BROKE THEN REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 19229196 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE TWO (X2) GRYPHON T BR ANCHOR W/OC ANCHORS WERE BROKEN OFF, REMOVED ALL THE BROKEN PARTS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166029 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE TWO (X2) GRYPHON T BR ANCHOR W/OC ANCHORS WERE BROKEN OFF, REMOVED ALL THE BROKEN PARTS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166027 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A STRENGTHENING FIXATION OF ELBOW LIGAMENT PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON T BR 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 18619210 ↗
• MalfunctionDec 6, 2023Break; Break

  T WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGERY ON (B)(6) 2023, THE GRYPHON T BR ANCHOR W/OC ANCHOR DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18276714 ↗
• MalfunctionDec 6, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGERY ON (B)(6) 2023, THE GRYPHON T BR ANCHOR W/OC ANCHOR DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18276695 ↗
• MalfunctionAug 1, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON T BR ANCHOR W/ORTHOCORD DEVICE BROKE OFF. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. 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 17439359 ↗
• MalfunctionAug 1, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON T BR ANCHOR W/ORTHOCORD DEVICE BROKE OFF. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. 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 17436384 ↗
• MalfunctionJul 13, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN CHINA THAT DURING AN ARTHROSCOPIC ANKLE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE GRYPHON T BR ANCHOR W/ORTHOCORD DEVICE BROKE OFF WHEN REMOVED FROM THE BONE TUNNEL. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15001122 ↗
• MalfunctionMar 3, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANKLE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE ON THE GRYPHON T BR ANCHOR W/OC DEVICE BROKE OFF. 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 13660053 ↗
• MalfunctionMar 3, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANKLE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE ON THE GRYPHON T BR ANCHOR W/OC DEVICE BROKE OFF. 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 13660049 ↗
• MalfunctionMar 9, 2021Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE OF THE LEFT ARM ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GRYPHON T BR ANCHOR W/ORTHOCORD DEVICE BROKE UPON INSERTION INTO THE BONE TUNNEL. ALL FRAGMENTS WERE RECOVERED. 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 11444895 ↗
• MalfunctionAug 31, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4 THAT DURING SHOULDER REPAIR, IT WAS OBSERVED THAT THE GRYPHON T BR ANCHOR W/ORTHOCORD DEVICE BROKE WHEN PLACED INTO THE BOREHOLE. ACCORDING TO THE REPORTER, HALF OF THE ANCHOR COULD BE SAVED WITH THE INSERTER BUT THE REST OF THE IMPLANT STAYED IN THE BOREHOLE AND WAS OVERDRILLED AFTERWARDS. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 7836887 ↗
• MalfunctionJun 14, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  UPON INSERTION OF GRYPHON BR ANCHOR INTO GLENOID PERFORMED BY DOCTOR, GRYPHON ANCHOR BROKE. ANOTHER ANCHOR WAS OPENED AND SURGERY CONTINUED WITH LITTLE DELAY AND NO ADVERSE EVENTS TO PATIENT. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7601764 ↗
• MalfunctionJun 14, 2018Break; Break

  UPON INSERTION OF GRYPHON BR ANCHOR INTO GLENOID PERFORMED BY DOCTOR, GRYPHON ANCHOR BROKE. ANOTHER ANCHOR WAS OPENED AND SURGERY CONTINUED WITH LITTLE DELAY AND NO ADVERSE EVENTS TO PATIENT. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7601353 ↗
• InjuryApr 30, 2018Break; Break

  ANCHOR BROKEN DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient; Tissue Damage

  MAUDE report 7474327 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073412, K150209. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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
• 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-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-2208-2011 · Feb 24, 2011 · Terminated
  DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD Product Code: 210811 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Bic