GRYPHON ORTHOCORD 210811Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886705001255), received between Jul 2, 2018 and Jan 22, 2026 — classified as 6 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING LABRAL REPAIR SURGERY, THE GRYPHON T BR DS ANCH W/OC ANCHOR DEVICE SLIPPED AND COULDN'T BE FIXED. 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 24149610 ↗
• MalfunctionJan 9, 2026Migration

  IT WAS REPORTED THAT DURING A HIP LABRAL REPAIR PROCEDURE, THE ANCHOR ON THE GRYPHON T BR DS ANCH W/OC DEVICE PULLED OUT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT 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 24021235 ↗
• MalfunctionJun 23, 2025Break; Migration; Break; Migration

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A ARTHROSCOPIC SHOULDER STABILIZING SURGERY, IT WAS OBSERVED THAT A GRYPHON T BR DS ANCH W/OC DEVICE ANCHOR WAS IN A GRYPHON P BR DS ANCHOR W/OC ANCHOR PACKAGING. ACCORDING TO THE REPORTER, AS NO ONE EXPECTED IT, THE ANCHOR WAS USED LIKE A GRYPHON P DEVICE, AND THE ANCHOR BROKE AND PULLED OUT. THERE WAS A FIFTEEN MINUTE 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 22305942 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF THE FIFTH METATARSAL BASE FRACTURE IN THE LEFT FOOT SURGERY, IT WAS DISCOVERED THAT THE ANCHOR ON THE GRYPHON T BR DS ANCH W/OC DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 19905744 ↗
• MalfunctionJul 15, 2024Break; Break

  IT WAS REPORTED, BY THE SALES REP IN CHINA. THAT DURING, A HIP GLENOID LIGAMENT SURGICAL PROCEDURE ON (B)(6) 2024. THE 2X GRYPHON T BR DS ANCH W/OC DEVICE ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742775 ↗
• MalfunctionJul 15, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A HIP GLENOID LIGAMENT SURGICAL PROCEDURE ON (B)(6) 2024 THE 2X GRYPHON T BR DS ANCH W/OC DEVICE ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742772 ↗
• MalfunctionJul 11, 2024Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT DURING A HIP GLENOID LIGAMENT REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE GRYPHON T BR DS ANCH W/OC DEVICE WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER DEVICE TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM OCCURRED AGAIN. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 19719887 ↗
• MalfunctionJul 11, 2024Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT DURING A HIP GLENOID LIGAMENT REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE GRYPHON T BR DS ANCH W/OC DEVICE WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER DEVICE TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM OCCURRED AGAIN. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 19719756 ↗
• MalfunctionJun 19, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING A LIP REPAIR PROCEDURE, IT WAS DISCOVERED THAT WHEN THE SUTURE ON THE GRYPHON T BR DS ANCH W/OC WAS TIGHTENED, IT BROKE OFF. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 19566503 ↗
• MalfunctionJun 11, 2024Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE GRYPHON T BR DS ANCH W/OC DEVICE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. 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 19512725 ↗
• MalfunctionSep 25, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE OF THE HIP ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON T BR DS ANCHORS W/ORTHOCORD DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 17809837 ↗
• MalfunctionSep 25, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE OF THE HIP ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON T BR DS ANCHORS W/ORTHOCORD DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 17809818 ↗
• MalfunctionSep 25, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE OF THE HIP ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON T BR DS ANCHORS W/ORTHOCORD DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 17809694 ↗
• MalfunctionSep 25, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR PC-(B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE OF THE HIP ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON T BR DS ANCHORS W/ORTHOCORD DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 17809677 ↗
• MalfunctionSep 25, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE OF THE HIP ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON T BR DS ANCHORS W/ORTHOCORD 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 17809498 ↗
• MalfunctionApr 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2023, TWO GRYPHON T BR DS ANCHORS W/ORTHOCORD DEVICES WERE USED. ACCORDING TO THE REPORT, AFTER POSITIONING THE ANCHOR AND PASSING THE SUTURE THREAD THROUGH THE LABRUM, THERE WAS DISASSEMBLY OF THE THREAD FROM THE ANCHOR OCCURRED AT THE TIME OF SUTURE RETRIEVAL TO TIE THE KNOT. 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 16691796 ↗
• MalfunctionApr 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2023, TWO GRYPHON T BR DS ANCHORS W/ ORTHOCORD DEVICES WERE USED. ACCORDING TO THE REPORT, AFTER POSITIONING THE ANCHOR AND PASSING THE SUTURE THREAD THROUGH THE LABRUM, THERE WAS DISASSEMBLY OF THE THREAD FROM THE ANCHOR OCCURRED AT THE TIME OF SUTURE RETRIEVAL TO TIE THE KNOT. 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 16691777 ↗
• MalfunctionMar 3, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON T BR DS ANCH W/OC DEVICE BROKE. ALL THE BROKEN PARTS WERE REMOVED. 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 13660088 ↗
• MalfunctionFeb 28, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ARTHROSCOPIC HIP REPAIR OF GLENOID LIP PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON T BR DS ANCH W/OC DEVICE BROKE. ALL THE BROKEN PARTS WERE REMOVED. 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 13623861 ↗
• MalfunctionJan 10, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A KNEE SURGERY FOR PATELLAR DISLOCATION OF THE RIGHT KNEE ON (B)(6) 2021, IT WAS OBSERVED THAT BOTH THE SUTURE AND ANCHOR ON THE GRYPHON T BR DS ANCH W/OC DEVICE WERE BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. 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 13206918 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANKLE LIGAMENT REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE ON THE GRYPHON T BR DS ANCH W/OC DEVICE BROKE WHILE TIGHTENING. 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 12862881 ↗
• InjuryAug 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING SURGERY THREE GRYPHON T BR DS ANCHOR TRIED TO BE IMPLANTED, WHICH DETACHED AND COULD NOT BE IMPLANTED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED 3 DEVICES; PRODUCT CODE 210811, OF LOT L630469 WERE USED DURING THE PROCEDURE. IT WAS ALSO REPORTED THERE WAS AN HOUR SURGICAL DELAY WITH NO PATIENT CONSEQUENCES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ANCHOR; PRODUCT CODE 222245. THE AFFILIATE ALSO REPORTED THE FAILURE OF THE DEVICE OCCURRED WHEN THE SURGEON IMPLANTED THE ANCHOR AND THEN PULL THE SUTURES THE ANCHOR DETACHED. IT WAS STATED THE DEVICES ARE AVAILABLE FOR RETURN.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8920153 ↗
• InjuryAug 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING SURGERY THREE GRYPHON T BR DS ANCHOR TRIED TO BE IMPLANTED, WHICH DETACHED AND COULD NOT BE IMPLANTED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED 3 DEVICES; PRODUCT CODE 210811, OF LOT L630469 WERE USED DURING THE PROCEDURE. IT WAS ALSO REPORTED THERE WAS AN HOUR SURGICAL DELAY WITH NO PATIENT CONSEQUENCES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ANCHOR; PRODUCT CODE 222245. THE AFFILIATE ALSO REPORTED THE FAILURE OF THE DEVICE OCCURRED WHEN THE SURGEON IMPLANTED THE ANCHOR AND THEN PULL THE SUTURES THE ANCHOR DETACHED. IT WAS STATED THE DEVICES ARE AVAILABLE FOR RETURN.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8920105 ↗
• InjuryAug 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING SURGERY THREE GRYPHON T BR DS ANCHOR TRIED TO BE IMPLANTED, WHICH DETACHED AND COULD NOT BE IMPLANTED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED 3 DEVICES; PRODUCT CODE 210811, OF LOT L630469 WERE USED DURING THE PROCEDURE. IT WAS ALSO REPORTED THERE WAS AN HOUR SURGICAL DELAY WITH NO PATIENT CONSEQUENCES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ANCHOR; PRODUCT CODE 222245. THE AFFILIATE ALSO REPORTED THE FAILURE OF THE DEVICE OCCURRED WHEN THE SURGEON IMPLANTED THE ANCHOR AND THEN PULL THE SUTURES THE ANCHOR DETACHED. IT WAS STATED THE DEVICES ARE AVAILABLE FOR RETURN.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8920100 ↗
• InjuryAug 20, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA PHONE THAT DURING THE ARTHROSCOPIC LABRAL REPAIR OF SHOULDER JOINT PROCEDURE, WHEN INSERT THE GRYPHON T BR DS ANCH W/OC, THE DEVICES WERE BROKEN OFF. TWO OF THEM REMAINED IN THE PATIENT, ONE BROKEN PART WAS REMOVED FROM PATIENT AS THE PHOTO SHOWS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. AS THE MATERIAL IS BIO,THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGERY TIME WAS NOT DELAYED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8910227 ↗

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-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-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-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-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-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