HEALIX ADVANCE PERMACORDRecalls & reported problems across all models

We found 9 models of HEALIX ADVANCE PERMACORD by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 113 adverse event reports in the FDA's MAUDE database, received between Feb 23, 2018 and Sep 2, 2026 — classified as 17 injuries, 96 malfunctions.

The most frequently reported specific device problem is “Break” (71 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported HEALIX ADVANCE PERMACORD problems

HEALIX ADVANCE PERMACORD models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HEALIX ADVANCE PERMACORD 223129

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  58 reports
• HEALIX ADVANCE PERMACORD 223131

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  20 reports
• HEALIX ADVANCE PERMACORD 223128

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  16 reports
• HEALIX ADVANCE PERMACORD 223135

  Screw, fixation, bone
  7 reports
• HEALIX ADVANCE PERMACORD 223134

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  3 reports
• HEALIX ADVANCE PERMACORD 223137

  Screw, fixation, bone
  3 reports
• HEALIX ADVANCE PERMACORD 223130

  Screw, fixation, bone
  3 reports
• HEALIX ADVANCE PERMACORD 223133

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  2 reports
• HEALIX ADVANCE PERMACORD 223136

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  1 report

Recent HEALIX ADVANCE PERMACORD adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionApr 3, 2026Crack

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SURGEON EXPERIENCED THE HEALIX ADVANCE PERMACORD SUTURE DEVICE BREAKING AND FRAYING INTRAOPERATIVELY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780114 ↗
• MalfunctionApr 3, 2026Crack

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SURGEON EXPERIENCED THE HEALIX ADVANCE PERMACORD SUTURE DEVICE BREAKING AND FRAYING INTRAOPERATIVELY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780113 ↗
• MalfunctionMar 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, AFTER PREPARING THE PILOT HOLE IN THE HUMERAL HEAD, A 4.5 HEALIXADV PEEK ANC PCORD ANCHOR WAS INSERTED ACCORDING TO STANDARD TECHNIQUE. UPON INSERTION, THE ANCHOR FAILED TO MAINTAIN SUTURE INTEGRITY. THE SUTURES BECAME DETACHED FROM THE BOTTOM OF THE ANCHOR, INDICATING A FAILURE OF THE INTERNAL SUTURE-RETENTION MECHANISM. NO EXTERNAL DEFORMITIES, CRACKS, OR MATERIAL DEFECTS WERE NOTED ON THE OUTSIDE OF THE ANCHOR UPON INSPECTION. THE APPEARANCE SUGGESTED THAT THE INTERNAL BRIDGE OR INTERNAL SUTURE-RETENTION COMPONENT MAY HAVE FAILED. THE ANCHOR WAS SUBSEQUENTLY DISCARDED AND WAS NOT AVAILABLE FOR RETURN OR FURTHER ANALYSIS. NO PATIENT INJURY WAS REPORTED, AND AN ALTERNATIVE FIXATION METHOD WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568079 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 5.5 HEALIXADV BR3SUTANC PCORD DEVICE ANCHOR BROKE OFF DURING INSERTION. THE SURGEON STOPPED THE PROCEDURE AND SWITCHED TO ANOTHER DEVICE. 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 22741995 ↗
• 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 ↗

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