HEALIX ADVANCE PERMACORD 223135Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705024759), received between May 25, 2018 and Nov 20, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE 4.5 HEALIX ADV PEEK 3 SUTANC PCORD DEVICE, IT APPEARED THAT THE ANCHOR HAD A PIECE OF PLASTIC INTERPOSED BETWEEN THE ANCHOR AND THE INSERTER SHAFT. THE SURGEON IMMEDIATELY DISCARDED THIS UNIT FROM THE FIELD. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE UNIT IN QUESTION NEVER CAME INTO CONTACT WITH THE PATIENT. 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 23606579 ↗
• MalfunctionAug 26, 2025Crack; Crack

  IT WAS REPORTED THAT THE 4.5 HEALIXADVPEEK3SUTANC PCORD DEVICE TIP WAS CRACKED BEFORE USING PRODUCT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897490 ↗
• MalfunctionFeb 4, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR THE 4.5 HELAIX ADVANCE PEEK 3 SUTURE ANCHOR W/  PERMACORD BROKE DURING INSERTION. THE PHYSICIAN REMOVED ALL THE FRAGMENTS GENERATED. 5 MINUTES DELAY TO THE PROCEDURE WERE REPORTED. NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ANCHOR.

  Patient problems: Not Applicable

  MAUDE report 9667919 ↗
• MalfunctionJan 2, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE OUTER TIP ON THE 4.5 HEALIX ADVANCE PEEK THREE-SUTURE ANCHOR DEVICE FRACTURED (BROKE) DURING INSERTION. THE SALES REP STATED THAT FRAGMENTS WERE CREATED AND REMOVED EASILY WITHOUT ADDITIONAL SURGICAL INTERVENTION. THE CASE WAS COMPLETED WITH NO PATIENT HARM OR TIME DELAY USING THE SAME BONE HOLE. THERE WERE NO PROCEDURAL FACTORS THAT CONTRIBUTED TO THE EVENT BUT POTENTIAL HARD BONE WAS A FACTOR. THE ANCHOR WAS DISCARDED BY THE CUSTOMER. 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 8209841 ↗
• MalfunctionJul 27, 2018Break; Break

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE ANCHOR BROKE/SNAPPED IN HALF WHEN THE SURGEON TURNED THE ANCHOR COUPLE OF TIMES. THE SURGEON COMPLETED THE PROCEDURE WITH A LIKE DEVICE; THERE WERE NO CONSEQUENCES AND NO DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7727741 ↗
• MalfunctionJul 26, 2018Loss of or Failure to Bond; Positioning Problem; Loss of or Failure to Bond; Positioning Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMER¿S HEALIX ADVANCE (PEEK) 4.5MM ANCHOR WITH PERMACORD 3 SUTURE PULLED OUT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER SAME TYPE, LARGER SIZE 5.5MM ANCHOR IN THE SAME BONEHOLE. THE SALES REP REPORTED THAT THE BONEHOLE WAS PREPPED WITH THE AWL AND THERE WAS HOLE DIVERGENCE WHEN THE SURGEON REINSERTED THE AWL. THE SALES REP REPORTED THAT THE BONE QUALITY WAS SOFTER THAN NORMAL. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. 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 7722382 ↗
• MalfunctionMay 25, 2018Crack; Migration or Expulsion of Device; Crack; Migration or Expulsion of Device

  PATIENT WAS BROUGHT BACK FOR A REVISION ROTATOR CUFF REPAIR. WHEN EXAMINING THE RETEAR, WE NOTICED THAT THE FIRST ANCHOR HAD PULLED OUT AND CRACKED ALONG THE SIDE OF THE ANCHOR. PATIENT CONSEQUENCE? UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7544354 ↗

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