HEALIX ADVANCE PERMACORD 223129Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10886705024735), received between Feb 23, 2018 and Sep 2, 2026 — classified as 8 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Break” (41 reports).

1 other recall cover devices cleared under the same FDA submission (K073412, K100012, K133794); 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569875 ↗
• MalfunctionJan 12, 2026Break; Difficult to Advance

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGICAL PROCEDURE, THE 4.5 HEALIXADV BR3SUTANC PCORD DEVICE WHEN THE SURGEON TRIED TO INSERT THE ANCHOR, THE TIP BROKE OFF AND IT COULD NOT BE INSERTED. THERE WERE NO BROKEN PART REMAINS INSIDE THE BODY, BUT THE SURGEON COMMENTED THAT IT MAY HAVE BEEN TOO FRAGILE. THE SURGERY WAS SUCCESSFULLY COMPLETED USING ANOTHER PRODUCT. THERE WERE NO SURGICAL DELAY AND NO HARM TO THE PATIENT. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037031 ↗
• MalfunctionDec 18, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE 4.5 HEALIXADV BR3SUTANC PCORD DEVICE, WHEN THE SURGEON ATTEMPTED TO USE THE ANCHOR, IT WAS UNABLE TO BE INSERTED BECAUSE IT DID NOT ROTATE PROPERLY AND DID NOT GO INTO THE BONE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23840429 ↗
• MalfunctionDec 3, 2025Crack; Crack

  IT WAS REPORTED THAT THIS WAS A ARTHROSCOPIC ROTATOR CUFF REPAIR ON SHOULDER JOINT FOR ROTATOR CUFF TEAR PERFORMED, THE 4.5 HEALIXADV BR3SUTANC PCORD DEVICE, WHEN THE SURGEON INSERTED THE PRODUCT IN QUESTION INTO THE BODY AND ATTEMPTED TO INSERT THE TIP OF THE ANCHOR INTO THE BONE FORAMEN, AN ARTHROSCOPIC IMAGE SHOWED WHAT APPEARED TO BE A CRACK AT THE TIP OF THE ANCHOR. THE SURGEON HAD CONCERNS ABOUT USING THE PRODUCT IN QUESTION AND DISCONTINUED ITS USE. ANOTHER PRODUCT WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS 30 MINUTES SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708274 ↗
• MalfunctionApr 2, 2025Break; Device-Device Incompatibility; Migration; Break; Device-Device Incompatibility; Migration

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT WHEN THE 4.5 HEALIXADV BR3SUTANC PCORD DEVICE WAS INSERTED, THE ANCHOR SUTURE WAS DIFFICULT TO SLIDE. AFTER ATTEMPTING TO SLIDE IT SEVERAL TIMES, THE EYELET BROKE, CAUSING THE ANCHOR TO DISENGAGE. IT WAS REPORTED THAT NO FRAGMENTS WERE PRESENT IN THE PATIENT, AS CONFIRMED BY THE SURGEON THROUGH X-RAY. 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 21751826 ↗
• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SHOULDER SURGERY, IT WAS OBSERVED THAT WHEN THE 4.5 HEALIXADV BR3SUTANC PCORD DEVICE WAS INSERTED INTO THE BONE HOLE AND DEVICE WAS TURNED, THE ANCHOR BROKE. THE ANCHOR WAS REMOVED FROM THE PATIENT'S BODY AND ANOTHER ANCHOR WAS USED AND THE SURGERY WAS COMPLETED. THERE WERE NO PIECES LEFT IN THE BODY, AND NO HARM TO THE PATIENT. THERE WAS A THIRTY 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 21342358 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY ON THE RIGHT SHOULDER FOR A RIGHT SHOULDER ROTATOR CUFF TEAR, IT WAS DISCOVERED THAT THE PORTION OF THE ANCHOR ON THE 4.5 HEALIXADV BR3SUTANC PCORD DEVICE CONTAINING THE SUTURES BROKE OFF. ACCORDING TO THE REPORTER THE SURGEON ATTEMPTED A DOUBLE-ROW SUTURE FOR THE SMALL SSP TEAR. A HEALIX PERMACORD ANCHOR WAS INSERTED MEDIALLY, WHILE A HEALIX BR 4.5 (ORTHOCORD) ANCHOR WAS PLACED LATERALLY. THE ROTATOR CUFF WAS THREADED USING ARTHREX'S SCORPION. DETERMINING THAT TWO MEDIAL SUTURES WERE SUFFICIENT, THE SURGEON REMOVED ONE AND THREADED THE REMAINING ONE WITH A MATTRESS STITCH, LEAVING THE OTHER TEMPORARILY UNTHREADED. SIMILARLY, TWO ORTHOCORDS WERE THREADED ON THE LATERAL SIDE, WITH ONE TEMPORARILY LEFT UNTHREADED. AFTER COMPLETING THE THREADING, WHEN THE SURGEON ATTEMPTED TO PULL THE SUTURES FROM THE ANCHORS IN THE MEDIAL ROW, SOMETHING FELT OFF, PROMPTING THE SURGEON TO STOP. THE SALES REPRESENTATIVE ASKED THE SURGEON HOW THINGS WERE GOING AND NOTICED THAT THE SUTURES WERE COMING OUT. THE SURGEON INITIALLY SUSPECTED A ¿CUT-OUT¿ BUT FOUND IT UNLIKELY THAT THE SUTURES WOULD COMPLETELY DETACH FROM THE ANCHOR. WHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321905 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED FROM JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS DISCOVERED THAT WHEN THE ANCHOR TIP OF THE 4.5 HEALIXADV BR3SUTANC PCORD DEVICE WAS INSERTED INTO THE HOLE CREATED BY AN OWL, THE ANCHOR TIP BROKE OFF AND COULD NOT BE INSERTED. THERE WAS THIRTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. 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 19906245 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED FROM JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE PERFORMED SIX MONTHS AGO ON AN UNKNOWN DATE, A 4.5 HEALIXADV BR3SUTANC PCORD WAS USED. ACCORDING TO THE REPORT, AFTER SURGERY, THE PATIENT SUSPECTED OF BEING INFECTED. IT WAS REPORTED THAT THE SUSPECTED INFECTION WAS DISCOVERED THROUGH AN MRI THAT SHOWED THAT THE AREA WHERE THE HEALIX USED WAS WHITE. IT WAS REPORTED THAT THE HOSPITAL WAS CURRENTLY CONFIRMING THE INFECTION. IT WAS REPORTED THAT ALTHOUGH THERE WERE NO BACTERIA, THERE WERE WHITE BLOOD CELLS. IT WAS REPORTED THAT THE PATIENT¿S SYMPTOMS WERE NOT SIGNIFICANT, AND THE CRP READING WAS ABOUT 1.7. IT WAS REPORTED THAT ABOUT 1CC OF JELLY-LIKE SUBSTANCE CAME OUT. IT WAS REPORTED THAT IT WAS UNCLEAR WHETHER THIS SUBSTANCE WAS CAUSED BY INFECTION OR BY AN ABSORPTION OF THE ANCHOR. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body Reaction; Unspecified Infection

  MAUDE report 19476561 ↗
• MalfunctionApr 24, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP FROM JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) PROCEDURE FOR A SHOULDER ROTATOR CUFF TEAR, IT WAS DISCOVERED THAT THE ANCHOR PART OF THE HEALIX ADVANCEBR 3 SUTURE ANCHOR W/ PERMACORD TCP/PLGA ABSORBABLE ANCHOR DEVICE BROKE OFF. THE BROKEN ANCHOR WAS REMOVED BY FORCEPS. THERE WAS A THIRTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. 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 19173446 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY FOR A ROTATOR CUFF TEAR ON (B)(6) 2023, IT WAS OBSERVED THAT THE THE TIP OF THE 4.5 HEALIXADV BR3SUTANC PCORD DEVICE, THE PART WITHOUT THREADS, BROKE OFF WHEN THE SURGEON WAS INSERTING THE IMPANT ALTHOUGH THE SURGEON DID NOT APPLY ANY EXCESSIVE FORCE. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. THERE WAS NO BROKEN FRAGMENT LEFT IN THE PATIENT¿S BODY. THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318088 ↗
• MalfunctionJul 28, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE  BR 3 SUTURE  ANCHOR W/ PERMACORD DEVICE SUDDENLY BROKE AFTER ONE ROTATION UPON INSERTION. ACCORDING TO THE REPORT, THE DAMAGED PART WAS ABOUT THE FIRST THREAD ON THE DISTAL SIDE. 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 17414334 ↗
• MalfunctionJun 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SUTURES ON THE 4.5 HEALIX ADVANCE  BR 3 SUTURE  ANCHOR W/ PERMACORD DEVICE PULLED OUT WHEN TYING WHILE THE ANCHOR WAS ALREADY INSERTED INSIDE THE PATIENT'S BODY. IT WAS UNKNOWN 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 17210963 ↗
• InjuryApr 17, 2023Break; Break

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, FOUR 4.5 HEALIX ADVANCE  BR 3 SUTURE  ANCHOR W/ PERMACORD DEVICES WERE IMPLANTED. ACCORDING TO THE REPORT, ON (B)(6) 2023 - A POST-OP MRI FOLLOW-UP FOUND THAT THE ROTATOR CUFF DID NOT REPAIR. IT WAS REPORTED THAT ON (B)(6) 2023, A SECOND POST-OP MRI CONFIRMED THAT THE ROTATOR CUFF DID NOT REPAIR. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT HAD A REVISION SURGERY WHERE IT WAS OBSERVED THAT THREE OF THE FOUR ANCHORS FAILED AS THE TIP HOLDING BRIDGE OF SUTURE WAS BROKEN; AND THEREFORE, THE SUTURES WERE DETACHED. IT WAS REPORTED THAT THE THREE BROKEN ANCHORS WERE REPLACED. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16754872 ↗
• InjuryApr 17, 2023Break; Break

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, FOUR 4.5 HEALIX ADVANCE  BR 3 SUTURE  ANCHOR W/ PERMACORD DEVICES WERE IMPLANTED. ACCORDING TO THE REPORT, ON (B)(6) 2023 - A POST-OP MRI FOLLOW-UP FOUND THAT THE ROTATOR CUFF DID NOT REPAIR. IT WAS REPORTED THAT ON (B)(6) 2023, A SECOND POST-OP MRI CONFIRMED THAT THE ROTATOR CUFF DID NOT REPAIR. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT HAD A REVISION SURGERY WHERE IT WAS OBSERVED THAT THREE OF THE FOUR ANCHORS FAILED AS THE TIP HOLDING BRIDGE OF SUTURE WAS BROKEN; AND THEREFORE, THE SUTURES WERE DETACHED. IT WAS REPORTED THAT THE THREE BROKEN ANCHORS WERE REPLACED. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16754855 ↗
• InjuryApr 17, 2023Break; Break

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(4)2023, FOUR 4.5 HEALIX ADVANCE  BR 3 SUTURE  ANCHOR W/ PERMACORD DEVICES WERE IMPLANTED. ACCORDING TO THE REPORT, ON (B)(4) 2023 - A POST-OP MRI FOLLOW-UP FOUND THAT THE ROTATOR CUFF DID NOT REPAIR. IT WAS REPORTED THAT ON (B)(6) 2023, A SECOND POST-OP MRI CONFIRMED THAT THE ROTATOR CUFF DID NOT REPAIR. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT HAD A REVISION SURGERY WHERE IT WAS OBSERVED THAT THREE OF THE FOUR ANCHORS FAILED AS THE TIP HOLDING BRIDGE OF SUTURE WAS BROKEN; AND THEREFORE, THE SUTURES WERE DETACHED. IT WAS REPORTED THAT THE THREE BROKEN ANCHORS WERE REPLACED. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16754846 ↗
• MalfunctionMar 9, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE  BR 3 SUTURE  ANCHOR W/ PERMACORD DEVICE BROKE UPON INSERTION INTO THE MEDIAL HUMERAL HEAD. ACCORDING TO THE REPORT, THE EVENT OCCURRED WHEN THE DEVICE WAS PUSHED IN AND TURNED AS THE SURGEON TRIED TO INSERT THE DEVICE AFTER MAKING A BURR HOLE WITH A DEDICATED AWL, BUT THE SURGEON HAD A DIFFICULTY IN INSERTING THE ANCHOR BECAUSE THE TIP OF THE ANCHOR (NON-THREADED PART) DID NOT GO INTO THE BURR HOLE SMOOTHLY. IT WAS REPORTED THAT THE BROKEN PART WAS COMPLETELY IN ONE PIECE AND WAS REMOVED IN THE PATIENT¿S BODY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16517318 ↗
• MalfunctionFeb 1, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE  BR 3 SUTURE  ANCHOR W/ PERMACORD DEVICE BROKE UPON INSERTION. 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 16277573 ↗
• MalfunctionJan 5, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HEALIX ADVANCE  BR 3 SUTURE  ANCHOR W/ PERMACORD DEVICE BROKE UPON INSERTION. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102927 ↗
• MalfunctionDec 28, 2022Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material; Appropriate Device Problem Term/Code Not Available; Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE  BR 3 SUTURE  ANCHOR W/ PERMACORD DEVICE BECAME UNCLEAN WHEN A NURSE OPENED THE PACKAGE. ACCORDING TO THE REPORT, THE NURSE COMPLAINED THAT THE PACKAGE WAS VERY ADHESIVE WHICH DID NOT ALLOW FOR SAFE OPENING. IT WAS FURTHER REPORTED THAT THE SURGEON ALSO REQUESTED IMPROVEMENT BECAUSE THE PACKAGE OF THE DEVICE WAS DIFFICULT TO OPEN. 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 16060651 ↗
• MalfunctionNov 15, 2022Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A SUTURE BRIDGING PROCEDURE TREATING SUPRASPINATUS TEAR ON (B)(6) 2022, IT WAS OBSERVED THAT TWO 4.5 HEALIX ADVANCE  BR 3 SUTURE  ANCHOR W/ PERMACORD DEVICES UPON INSERTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15800991 ↗
• MalfunctionNov 15, 2022Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A SUTURE BRIDGING PROCEDURE TREATING SUPRASPINATUS TEAR ON (B)(6) 2022, IT WAS OBSERVED THAT TWO 4.5 HEALIX ADVANCE  BR 3 SUTURE  ANCHOR W/ PERMACORD DEVICES UPON INSERTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15800946 ↗
• MalfunctionNov 8, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR TIP (DISTAL SUTURE BRIDGE) WAS BROKEN ON THE 4.5 HEALIX ADVANCE  BR 3 SUTURE  ANCHOR W/ PERMACORD DEVICE. 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 15755677 ↗
• MalfunctionOct 5, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE  BR 3 SUTURE  ANCHOR W/ PERMACORD DEVICE BROKE AS SOON AS IT WAS INSERTED INTO THE BURR HOLE AFTER MAKING A PREPARATORY BURR HOLE. ACCORDING TO THE REPORT, THE SURGEON SUSPECTED THAT THE DEVICE HAD BEEN BROKEN FROM THE BEGINNING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15545272 ↗
• MalfunctionSep 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE CAME OFF THE ANCHOR ON THE 4.5 HEALIX ADVANCE  BR 3 SUTURE  ANCHOR W/ PERMACORD DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393858 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073412, K100012, K133794. One submission often covers many models, so check the product and lot details in each record.

• 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