GRYPHON PROKNOT PERMACORD 210820Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 10886705024025), received between Jun 18, 2018 and May 4, 2026 — classified as 8 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Break” (62 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 25 most recent of 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Migration

  THIS IS 2 OF 2 ASSOCIATED WITH (B)(4). IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY, AFTER SUCCESSFULLY USING TWO GRYPHON PROKNOTS WITH DIFFERENT LOTS, THEY TRIED USING TWO GRYPHON PROKNOTS THAT PULLED DIRECTLY OUT OF BONE WHEN TYING THE KNOTS. THE SURGEON PERFORMED THE EXACT SAME PROCEDURE AND STEPS WITH THE ANCHORS AS WITH THE PREVIOUS TWO DEVICES. THE BONE QUALITY WAS GREAT. FOR SOME REASON THESE TWO GRYPHON PROKNOTS PULLED OUT WITH VERY LITTLE TENSION PUT ON THEM. NO PATIENT HARM OCCURRED. A DELAY OF 25 MINUTES IN THE CASE WAS A RESULT, AND SURGEON USED A COMPETITIVE PRODUCT TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067748 ↗
• MalfunctionMay 4, 2026Migration

  THIS IS 1 OF 2 ASSOCIATED WITH (B)(4). IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY, AFTER SUCCESSFULLY USING TWO GRYPHON PROKNOTS WITH DIFFERENT LOTS, THEY TRIED USING TWO GRYPHON PROKNOTS THAT PULLED DIRECTLY OUT OF BONE WHEN TYING THE KNOTS. THE SURGEON PERFORMED THE EXACT SAME PROCEDURE AND STEPS WITH THE ANCHORS AS WITH THE PREVIOUS TWO DEVICES. THE BONE QUALITY WAS GREAT. FOR SOME REASON THESE TWO GRYPHON PROKNOTS PULLED OUT WITH VERY LITTLE TENSION PUT ON THEM. NO PATIENT HARM OCCURRED. A DELAY OF 25 MINUTES IN THE CASE WAS A RESULT, AND SURGEON USED A COMPETITIVE PRODUCT TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067746 ↗
• MalfunctionFeb 13, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, ALTHOUGH THE GRYPHON BR W/ PROKNOT WAS USED ACCORDING TO THE PROCEDURE MANUAL, THE KNOT DID NOT PASS THROUGH THE POST THREAD, MAKING IT IMPOSSIBLE TO SUTURE. AN ADDITIONAL PRODUCT FROM THE SAME LOT WAS USED, AND THE SURGERY WAS COMPLETED WITHOUT INCIDENT. THERE WAS A 30 MINUTE SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335190 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE GRYPHON BR W/ PROKNOT DEVICE WAS BEING USED WHEN THE ANCHOR FRACTURED DOWN THE CENTER WHILST "MALLETING" IN. IT IS UNKNOWN WHETHER ANOTHER 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 23887889 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, WHEN THE SURGEON ATTEMPTED TO INSERT THE GRYPHON BR W/ PROKNOT ANCHOR DEVICE INTO THE BONE HOLE IT WAS OBSERVED THAT TIP OF THE ANCHOR BROKE OFF. ANOTHER PRODUCT WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT NO PIECES OF THE DEVICE WERE LEFT IN THE BODY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894169 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE; AFTER CREATING A BURR HOLE, THE SURGEON ATTEMPTED TO INSERT THE ANCHOR OF THE GRYPHON BR W/ PROKNOT DEVICE INTO THE BURR HOLE, BUT THE TIP OF THE ANCHOR BROKE OFF. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE 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 22873718 ↗
• MalfunctionJul 2, 2025Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE GRYPHON BR W/ PROKNOT DEVICE WAS OPENED, THE TIP OF THE ANCHOR SEEMED TO BE CHIPPED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE IS NO POSSIBILITY OF FRAGMENTS BEING LEFT IN THE BODY SINCE THE ANCHOR IN QUESTION WAS NOT INSERTED IN THE BODY. 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 22383830 ↗
• MalfunctionMay 16, 2025Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY BANKART SURGICAL PROCEDURE THE GRYPHON BR W/ PRO-KNOT DEVICE TWO IMPLANTS COULD NOT BE DEPLOYED DUE TO THE DAMAGED IN THE KNOT/ SUTURE STRAND. THE SURGEON THEN USED THE GRYPHON P WHICH WORKED PROPERLY IN THE PATIENT. THERE WAS ABOUT A TEN DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039207 ↗
• MalfunctionMay 16, 2025Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY BANKART SURGICAL PROCEDURE THE GRYPHON BR W/ PROKNOT DEVICE TWO IMPLANTS COULD NOT BE DEPLOYED DUE TO THE DAMAGED IN THE KNOT/ SUTURE STRAND. THE SURGEON THEN USED THE GRYPHON P WHICH WORKED PROPERLY IN THE PATIENT. THERE WAS ABOUT A TEN DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039161 ↗
• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC BANKART REPAIR PROCEDURE FOR SHOULDER INSTABILITY IT WAS OBSERVED THAT WHEN THE SURGEON WAS PULLING THE FREE END OF THE SUTURE TO PASS THROUGH THE LABRUM, IT LOOKED AS IF THE INNER PART OF THE GRYPHON BR W/ PROKNOT ANCHOR BROKE, EFFECTIVELY UNLOADING THE ANCHOR. IT WAS REPORTED THAT TWO ADDITIONAL GRYPHON BR W/ PROKNOT ANCHORS WERE USED, AND THE SAME PROBLEM OCCURRED. IT WAS REPORTED THAT THE ANCHOR BODY REMAINED EMBEDDED IN GLENOID BONE BUT THERE WAS NO MORE SUTURE RUNNING THROUGH IT. IT WAS REPORTED THAT ANOTHER COMPETITOR¿S ANCHOR WAS SUCCESSFULLY USED INSTEAD. IT WAS REPORTED THAT THERE WAS A 15-MINUTE CASE DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459356 ↗
• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC BANKART REPAIR PROCEDURE FOR SHOULDER INSTABILITY IT WAS OBSERVED THAT WHEN THE SURGEON WAS PULLING THE FREE END OF THE SUTURE TO PASS THROUGH THE LABRUM, IT LOOKED AS IF THE INNER PART OF THE GRYPHON BR W/ PROKNOT ANCHOR BROKE, EFFECTIVELY UNLOADING THE ANCHOR. IT WAS REPORTED THAT TWO ADDITIONAL GRYPHON BR W/ PROKNOT ANCHORS WERE USED, AND THE SAME PROBLEM OCCURRED. IT WAS REPORTED THAT THE ANCHOR BODY REMAINED EMBEDDED IN GLENOID BONE BUT THERE WAS NO MORE SUTURE RUNNING THROUGH IT. IT WAS REPORTED THAT ANOTHER COMPETITOR¿S ANCHOR WAS SUCCESSFULLY USED INSTEAD. IT WAS REPORTED THAT THERE WAS A 15-MINUTE CASE DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459270 ↗
• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC BANKART REPAIR PROCEDURE FOR SHOULDER INSTABILITY IT WAS OBSERVED THAT WHEN THE SURGEON WAS PULLING THE FREE END OF THE SUTURE TO PASS THROUGH THE LABRUM, IT LOOKED AS IF THE INNER PART OF THE GRYPHON BR W/ PROKNOT ANCHOR BROKE, EFFECTIVELY UNLOADING THE ANCHOR. IT WAS REPORTED THAT TWO ADDITIONAL GRYPHON BR W/ PROKNOT ANCHORS WERE USED, AND THE SAME PROBLEM OCCURRED. IT WAS REPORTED THAT THE ANCHOR BODY REMAINED EMBEDDED IN GLENOID BONE BUT THERE WAS NO MORE SUTURE RUNNING THROUGH IT. IT WAS REPORTED THAT ANOTHER COMPETITOR¿S ANCHOR WAS SUCCESSFULLY USED INSTEAD. IT WAS REPORTED THAT THERE WAS A 15-MINUTE CASE DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459204 ↗
• MalfunctionDec 10, 2024Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE WHILE USING 3X GRYPHON P BR DS ANCHOR W/OC DEVICE AND INFLOW TUBING FMS VUE 24PK, THE GRYPHON DEVICE WAS DAMAGED. THE ANCHORING OF THE DEVICE WHEN KNOTTING CAME OUT OF THE BONE OF THE PTE. THE FENESTRATED GUIDE WAS DAMAGED THERE WAS AN UNKNOWN AMOUNT OF DELAY TO THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO OTHER MEDICAL PROCEDURES WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 PF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894555 ↗
• MalfunctionNov 18, 2024Break; Break

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE EYELETS OF TWO (2) GRYPHON BR W/ PROKNOT DEVICES BROKE WHILE TYING THE KNOT ON THE PROKNOT ANCHORS. 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 20704801 ↗
• MalfunctionNov 18, 2024Break; Break

  REPORT 2 OF 2 FOR(B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE EYELETS OF TWO (2) GRYPHON BR W/ PROKNOT DEVICES BROKE WHILE TYING THE KNOT ON THE PROKNOT ANCHORS. 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 20704779 ↗
• MalfunctionOct 22, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN FRANCE THAT FOLLOWING A "BUTÉE LATARJET" PROCEDURE ON (B)(6) 2024, A GRYPHON BR W/ PROKNOT DEVICE WAS USED TO RECONSTRUCT THE CAPSULE. ACCORDING TO THE REPORTER, THE FIRST ANCHOR BROKE AT THE TOP OF THE SCREW THREAD. THERE WAS PATIENT INVOLVEMENT. IT WAS REPORTED THAT FRAGMENTS WERE GENERATED. 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 20506610 ↗
• MalfunctionOct 16, 2024Break; Break

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING BANKART REPAIR PROCEDURE, IT WAS OBSERVED THAT THE SUTURE BRIDGE ON THREE GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY DEVICES BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF EIGHT MINUTES. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20464289 ↗
• MalfunctionOct 16, 2024Break; Break

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING BANKART REPAIR PROCEDURE, IT WAS OBSERVED THAT THE SUTURE BRIDGE ON THREE GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY DEVICES BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF EIGHT MINUTES. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463080 ↗
• MalfunctionOct 16, 2024Break; Break

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING BANKART REPAIR PROCEDURE, IT WAS OBSERVED THAT THE SUTURE BRIDGE ON THREE GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY DEVICES BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF EIGHT MINUTES. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462690 ↗
• MalfunctionSep 25, 2024Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, A GRYPHON BR W/ PROKNOT DEVICE WAS USED. ACCORDING TO THE REPORT, THE DEVICE DID NOT IMPACT AND BROKE AT THE END OF THE IMPACTION WHEN THE GUIDE WAS WITHDRAWN ABOUT 2MM. 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 20305035 ↗
• MalfunctionSep 24, 2024Break; Difficult to Advance; Break; Difficult to Advance

  THIS IS REPORT 4 OF 4 FOR (B)(4). IT WAS REPORTED THAT DURING A BANKART REPAIR PROCEDURE, A GRYPHON BR W/ PROKNOT DEVICE WAS USED. ACCORDING TO THE REPORT, THE DEVICE DID NOT IMPACT AND BROKE AT THE END OF THE IMPACTION WHEN THE GUIDE WAS WITHDRAWN ABOUT 2MM. THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE. 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 20293869 ↗
• MalfunctionSep 24, 2024Break; Difficult to Advance; Break; Difficult to Advance

  THIS IS REPORT 3 OF 4 FOR (B)(4). IT WAS REPORTED THAT DURING A BANKART REPAIR PROCEDURE, A GRYPHON BR W/ PROKNOT DEVICE WAS USED. ACCORDING TO THE REPORT, THE DEVICE DID NOT IMPACT AND BROKE AT THE END OF THE IMPACTION WHEN THE GUIDE WAS WITHDRAWN ABOUT 2MM. THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE. 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 20293831 ↗
• MalfunctionSep 24, 2024Break; Difficult to Advance; Break; Difficult to Advance

  THIS IS REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED THAT DURING A BANKART REPAIR PROCEDURE, A GRYPHON BR W/ PROKNOT DEVICE WAS USED. ACCORDING TO THE REPORT, THE DEVICE DID NOT IMPACT AND BROKE AT THE END OF THE IMPACTION WHEN THE GUIDE WAS WITHDRAWN ABOUT 2MM. THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE. 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 20293824 ↗
• MalfunctionSep 24, 2024Break; Difficult to Advance; Break; Difficult to Advance

  THIS IS REPORT 1 OF 4 FOR (B)(4). IT WAS REPORTED THAT DURING A BANKART REPAIR PROCEDURE, A GRYPHON BR W/ PROKNOT DEVICE WAS USED. ACCORDING TO THE REPORT, THE DEVICE DID NOT IMPACT AND BROKE AT THE END OF THE IMPACTION WHEN THE GUIDE WAS WITHDRAWN ABOUT 2MM. THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE. 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 20293813 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE FIVE (X5) GRYPHON FLEX BIOCRYL STRAIGHT DEVICES AND ONE GRYPHON BR W/ PROKNOT DEVICE HAD 4 ANCHORS BRAKE DURING INSERTION AND 2 ANCHORS THE LEVER COULD NOT BE ENGAGED, THE ANCHORS PULLED OUT WHEN REMOVING THE INSERTER. ONE OF THE DEVICES WAS BROKEN. ALTERNATIVE DEVICES WERE USED TO COMPLETE THE REPAIR. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20149701 ↗