HEALIX ADVANCE PERMACORD 223128Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886705024803), received between Aug 19, 2018 and Aug 25, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438895 ↗
• MalfunctionJun 16, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE HEALIX ADVANCE PERMACORD ANCHOR BROKE IN HALF AFTER THE FIRST HALF TURN OF THE INSERTER. BONE QUALITY WAS NORMAL, LEADING TO BELIEVE IT WAS AN ANCHOR ISSUE. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO DELAY. ANOTHER DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25517044 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE THE 4.5 HEALIXADV BR ANC PCORD DEVICE BROKE UPON INSERTION. THE SURGEON WAS ABLE TO OPEN A DIFFERENT ANCHOR AND GET THE ANCHOR TO INSERT WITHOUT ISSUE. THERE WERE NO REPORTS OF DELAY IN THE PROCEDURE REPORTED. THERE WAS PATIENT INVOLVEMENT. 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 21079985 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE 4.5 HEALIXADV BR ANC PCORD DEVICE BROKE WHEN SCREWING IT IN. 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 18142845 ↗
• MalfunctionNov 10, 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 4.5 HEALIX ADVANCE BR ANCHOR W/ PERMACORD, SIZE 2 BROKE AFTER INSERTION WHILE SURGEON WAS TRYING TO PULL THE SUTURE TO CHECK FIXATION. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 10 MINUTES. 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 15776756 ↗
• MalfunctionNov 10, 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 4.5 HEALIX ADVANCE BR ANCHOR W/ PERMACORD, SIZE 2 BROKE AFTER INSERTION WHILE SURGEON WAS TRYING TO PULL THE SUTURE TO CHECK FIXATION. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 10 MINUTES. 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 15774557 ↗
• MalfunctionJul 27, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE BR ANCHOR W/ PERMACORD, SIZE 2 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 15112913 ↗
• MalfunctionJul 5, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY WITH ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE BR ANCHOR W/ PERMACORD DEVICE BROKE UPON INSERTION IN THE HUMERUS. ACCORDING TO THE REPORT, THE SURGEON BARELY TURNED THE ANCHOR TO SPIN INTO THE BONE WHEN IT BROKE. 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 14917820 ↗
• InjurySep 24, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT AFTER INSERTING IMPLANT AND REMOVING THE SUTURES FROM THE SLIDER UNIT. X1 SUTURE FROM ANCHOR NOTED TO BE ALREADY DISLODGED. DECISION MADE BY SURGEON TO REMOVE SUTURE ANCHOR. UPON REMOVAL, NOTED ANCHOR TO BE BROKEN-AS SHOWN IN THE PICTURE ATTACHED. THERE WAS A SURGICAL DELAY OF 10 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED FRAGMENTS WERE NOT GENERATED BUT A NEW BONE HOLE WAS NEEDED. IT WAS REPORTED THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER LIKE DEVICE AND PATIENT HARM WAS NOT REPORTED.

  Patient problems: Injury; Not Applicable

  MAUDE report 10580994 ↗
• MalfunctionOct 28, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED BY THE AFFILIATE THAT THE 4.5 HEALIXADV BR ANC PCORD IS BROKEN. NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9246337 ↗
• MalfunctionJan 22, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 4.5 HEALIXADV BR ANC PCORD SUTURE DEVICE WAS STUCK IN THE SHAFT AND UNLOADED THE ANCHOR. ACCORDING TO THE REPORTER, THE EVENT OCCURRED WHEN THE DOCTOR WAS PULLING OUT THE INSERTER. IT WAS FURTHER REPORTED THAT THE SURGEON REINSERTED THE INSERTER SHAFT, REMOVED THE ANCHOR THEN PUT IN ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THIS CAUSED A FIVE MINUTE DELAY. 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 8266663 ↗
• MalfunctionAug 29, 2018Break; Break

  IT WAS REPORTED THAT THE TIP OF 4.5MM HEALIX ADVANCE BR ANCHOR BROKE OFF WHILE FINDING AWL HOLE. DR (B)(6) MENTIONED THERE WAS MINIMAL FORCE USED AND WHEN HE INSERTED THE NEXT ANCHOR IN THE SAME AWL HOLE HE SAID HE USED MORE FORCE THEN THE INITIAL ANCHOR THAT BROKE WITH NO PROBLEMS. THERE APPEARED TO BE MINIMAL FORCE USED FROM MY OBSERVATION. THE BROKEN ANCHOR WAS NOT INSERTED AND ALL PIECES WERE REMOVED. ADDED 3 MINUTES TO OPERATION TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7831249 ↗
• MalfunctionAug 19, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF PROCEDURE AFTER THE SURGEON INSERTED THE CUSTOMER'S 4.5 HEALIX ADVANCE WITH PERMACORD BR, THE ANCHOR BROKE IN HALF HORIZONTAL AND PULLED OUT WHEN TYING THE SUTURE. THE SALES REP STATED THAT THE SURGEON REMOVED THE BROKEN ANCHOR AND NO DEBRIS WAS LEFT IN THE PATIENT. THE SALES REP STATED THAT THE ANCHOR LOOKED DEFECTED AND THAT WHERE THE THREAD IS, IT APPEARS THAT IT WAS NOT MOLDED PROPERLY. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH A 5.5 HEALIX ADVANCE ANCHOR USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES BUT THERE WAS A FIVE MINUTE DELAY. THE SALES REP STATED THAT THE END RESULT WAS FINE AND DOCTOR WAS OK WITH THE OUTCOME. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7796276 ↗
• MalfunctionAug 19, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR THAT THE DISTAL TIP ON THREE OF THE CUSTOMER'S HEALIX ADVANCE BR ANCHOR WITH PERMACORD BROKE BELOW THE BOTTOM THREAD UPON INSERTION. THE SURGEON REMOVED THE BROKEN PIECES EACH TIME AND COMPLETED THE PROCEDURE WITH A FOURTH SAME TYPE, SAME SIZE ANCHOR FROM A DIFFERENT LOT. THE SURGEON USED THE SAME BONE HOLE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7796269 ↗
• MalfunctionAug 19, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR THAT THE DISTAL TIP ON THREE OF THE CUSTOMER'S HEALIX ADVANCE BR ANCHOR WITH PERMACORD BROKE BELOW THE BOTTOM THREAD UPON INSERTION. THE SURGEON REMOVED THE BROKEN PIECES EACH TIME AND COMPLETED THE PROCEDURE WITH A FOURTH SAME TYPE, SAME SIZE ANCHOR FROM A DIFFERENT LOT. THE SURGEON USED THE SAME BONE HOLE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7796268 ↗
• MalfunctionAug 19, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR THAT THE DISTAL TIP ON THREE OF THE CUSTOMER'S HEALIX ADVANCE BR ANCHOR WITH PERMACORD BROKE BELOW THE BOTTOM THREAD UPON INSERTION. THE SURGEON REMOVED THE BROKEN PIECES EACH TIME AND COMPLETED THE PROCEDURE WITH A FOURTH SAME TYPE, SAME SIZE ANCHOR FROM A DIFFERENT LOT. THE SURGEON USED THE SAME BONE HOLE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7796266 ↗

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