GRYPHON PROKNOT PERMACORD 210821Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886705024049), received between Aug 6, 2018 and Jul 18, 2025 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Migration” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE SURGERY, THE GRYPHON PEEK W/PROKNOT DEVICE ANCHOR WAS PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540720 ↗
• MalfunctionOct 24, 2024Migration; Migration

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE GRYPHON PEEK W/POKOT DEVICE CAME OUT AS THE SURGEON WAS KNOTTING AND LOWERING THE IMPLANT AFTER PLACEMENT. THERE WAS PATIENT INVOLVEMENT. 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 20527072 ↗
• MalfunctionNov 14, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON PEEK W/PROKNOT DEVICE SLIPPED OUT. 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 18133318 ↗
• MalfunctionOct 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN COLOMBIA THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6)2022 , IT WAS OBSERVED THAT ONE OF THE STRANDS ON THE GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY DEVICE WAS NOT PASSING THROUGH THE ANCHOR CAUSING THE THREAD TO COME OUT OF IT AND COULD NOT BE USED IN THE PATIENT. 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 15659414 ↗
• MalfunctionMay 20, 2022Migration; Migration

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHORS ON TWO GRYPHON PEEK W/PROKNOT DEVICES CAME OUT OF THE BONE UPON INSERTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461976 ↗
• MalfunctionMay 20, 2022Migration; Migration

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHORS ON TWO GRYPHON PEEK W/PROKNOT DEVICES CAME OUT OF THE BONE UPON INSERTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461903 ↗
• MalfunctionSep 22, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ACETABULAR LABRUM REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE ON THE GRYPHON PEEK W/PROKNOT DEVICE HAD A KNOT THAT IT WAS NOT ABLE TO MOVE FORWARD OR BACKWARD. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 12512723 ↗
• InjuryApr 26, 2021Migration; Migration

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6)2021, IT WAS OBSERVED THAT THE ANCHOR DEVICE PULLED OUT OF GLENOID BONE. ANOTHER LIKE DEVICE WAS INSERTED IN AN ALTERNATIVE LOCATION TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11726886 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED FROM AN AFFILIATE IN (B)(6) THAT DURING A REDUCTION OF THE SHOULDER JOINT PROCEDURE, IT WAS OBSERVED THAT THE GRYPHON PEEK ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL PIECES WERE REMOVED. ANOTHER LIKE 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 10969701 ↗
• MalfunctionJul 24, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE, WHILE USING A GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY, THE ANCHOR WAS NOT CONNECTED WITH SHAFT VERY CLOSELY, WHEN THEY KNOTED THE SUTURE, THE ANCHOR WAS PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10320687 ↗
• MalfunctionMar 10, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE THE GRYPHON PEEK W/PROKNOT PULLED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ANCHOR. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9813431 ↗
• InjuryDec 31, 2018Material Fragmentation; Material Fragmentation

  IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION THE CUSTOMER'S GRYPHON PEEK ANCHOR WITH PROKNOT UNLOADED WHILE PULLING THE INSERTER OUT. THE SALES REP STATED THAT THE CARD WAS STILL ATTACHED TO ONE END AND THE FREE END DIDN'T GET PULLED THROUGH THE ANCHOR. THE SALES REP STATED THAT IT SEEMED LIKE THE SUTURE BRIDGE ON THE ANCHOR WAS DEFECTIVE. THE CASE WAS COMPLETED WITH ANOTHER ANCHOR IN A DIFFERENT LOCATION WITH A ONE MINUTE DELAY. THE SALES REP STATED THERE IS NO NEED FOR SURGICAL INTERVENTION. THE SALES REP STATED THAT OTHER ANCHORS IN THE SAME LOT HAD NO PROBLEMS, BUT THE SALES REP DID NOT PROVIDE A LOT NUMBER. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED IF THERE WAS A PROLONGED HOSPITALIZATION. THE PATIENT'S STATUS POST-SURGERY WAS UNKNOWN. 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 8206261 ↗
• MalfunctionAug 21, 2018Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE PATIENT HAD AN EXTREMELY LOOSE CAPSULE SO THE SURGEON AND FELLOW DID A CAPSULAR SHIFT. THE FIRST ANCHOR WAS PLACED AND A LARGE BITE OF TISSUE WAS TAKEN, REPAIR COMPLETED CORRECTLY AND SUTURES CUT. WHEN THE FELLOW USED THE ARTHREX SUTURE LASSO TO BITE THE NEXT SECTION OF TISSUE FOR THE NEXT ANCHOR, THE HALF HITCH ON THE FIRST PRO-KNOT POPPED THROUGH THE CINCH PORT OF THE KNOT AND THE KNOT CONSTRUCT CAME UNDONE. SURGEON AND FELLOW PLACED SECOND ANCHOR AND REPAIRED THE SECOND PORTION OF TISSUE, WHEN TYING THE HALF-HITCH THE FELLOW BROKE A STRAND OF SUTURE AT THE KNOT. SURGEON THEN HAD THE FELLOW DRILL THROUGH THE FIRST PRO-KNOT WHICH SAT INFERIOR TO THE SECOND AND PLACED ANOTHER ANCHOR WHICH HAD NO ISSUES. THERE WERE A TOTAL OF FOUR ANCHORS WERE PLACED TO FINISH THE REPAIR. 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 WIL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800910 ↗
• MalfunctionAug 21, 2018Material Frayed; Material Frayed

  IT WAS REPORTED DURING SHOULDER REPAIR, THE SURGEON PLACED MULTIPLE PROKNOT ANCHORS FOR AN INSTABILITY REPAIR. WHEN TYING THE HALF-HITCH ON THE THIRD ANCHOR ONE OF THE SUTURE LIMBS SNAPPED AT THE KNOT. HE WAS ABLE TO FINISH THE CASE WITH MULTIPLE ANCHORS IN VARYING PLACES ALONG THE GLENOID. 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 7800893 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER PROCEDURE THREE OF THEIR GRYPHON PROKNOT PEEK SHOULDER ANCHORS¿ SUTURE SEPARATED MULTIPLE TIMES, DIVIDING INTO TWO ON THE FIRST UNLOADS. THE SURGEON USED REGULAR GRYPHONS TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO PATIENT CONSEQUENCES. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE BY MITEK COMPLAINTS ON (B)(6) 2015: THE SALES REP REPORTED THAT THE DEVICES WERE DISCARDED THEREFORE WILL NOT BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7750938 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER PROCEDURE THREE OF THEIR GRYPHON PROKNOT PEEK SHOULDER ANCHORS¿ SUTURE SEPARATED MULTIPLE TIMES, DIVIDING INTO TWO ON THE FIRST UNLOADS. THE SURGEON USED REGULAR GRYPHONS TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO PATIENT CONSEQUENCES. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE BY MITEK COMPLAINTS ON (B)(6) 2015: THE SALES REP REPORTED THAT THE DEVICES WERE DISCARDED THEREFORE WILL NOT BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7750937 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER PROCEDURE THREE OF THEIR GRYPHON PROKNOT PEEK SHOULDER ANCHORS¿ SUTURE SEPARATED MULTIPLE TIMES, DIVIDING INTO TWO ON THE FIRST UNLOADS. THE SURGEON USED REGULAR GRYPHONS TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO PATIENT CONSEQUENCES. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE BY MITEK COMPLAINTS ON (B)(6) 2015: THE SALES REP REPORTED THAT THE DEVICES WERE DISCARDED THEREFORE WILL NOT BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7750935 ↗