HEALIX ADVANCE BR ANCHOR w/DYNACORDRecalls & reported problems across all models
Medos International Sàrl · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 69
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 4 models of HEALIX ADVANCE BR ANCHOR w/DYNACORD by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2018 and Sep 10, 2026 — classified as 9 injuries, 60 malfunctions.
The most frequently reported specific device problem is “Break” (49 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
Reports received per month, all models
Most reported HEALIX ADVANCE BR ANCHOR w/DYNACORD problems
Device problems
- Break49
- Crack6
- Migration6
- Adverse Event Without Identified Device or Use Problem3
- Detachment of Device or Device Component3
- Material Split, Cut or Torn3
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- No Consequences Or Impact To Patient6
- Unspecified Tissue Injury4
- Foreign Body In Patient2
- Injury1
- Nerve Damage1
- Pain1
- Perforation of Vessels1
HEALIX ADVANCE BR ANCHOR w/DYNACORD models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HEALIX ADVANCE BR ANCHOR w/DYNACORD 222001Fastener, fixation, biodegradable, soft tissue57 reports
- HEALIX ADVANCE BR ANCHOR w/DYNACORD 222004Fastener, fixation, biodegradable, soft tissue8 reports
- HEALIX ADVANCE BR ANCHOR w/DYNACORD 222000Fastener, fixation, biodegradable, soft tissue3 reports
- HEALIX ADVANCE BR ANCHOR w/DYNACORD 222011Fastener, fixation, biodegradable, soft tissue1 report
Recent HEALIX ADVANCE BR ANCHOR w/DYNACORD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Break
It was reported that during an unspecified procedure, the HEALIX ADVANCE BR ANCHOR w/DYNACORD was broken off. All the broken parts were removed. Changed to another two HEALIX ADVANCE BR ANCHOR w/DYNACORD to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 3 of 3 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50712775 ↗MalfunctionSep 10, 2026Break
It was reported that during an unspecified procedure, the HEALIX ADVANCE BR ANCHOR w/DYNACORD was broken off. All the broken parts were removed. Changed to another two HEALIX ADVANCE BR ANCHOR w/DYNACORD to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 2 of 3 for (b)(4)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50712774 ↗MalfunctionSep 10, 2026Break
It was reported that during an unspecified procedure, the HEALIX ADVANCE BR ANCHOR w/DYNACORD was broken off. All the broken parts were removed. Changed to another two HEALIX ADVANCE BR ANCHOR w/DYNACORD to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 1 of 3 for (b)(4)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50712769 ↗MalfunctionSep 4, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50611959 ↗MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50457852 ↗MalfunctionJun 16, 2026Break
IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE HEALIX ADVANCE BR ANCHOR W/DYNACORD DEVICE ANCHOR BROKE OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25524075 ↗MalfunctionJun 8, 2026Crack
IMPLANT WAS USED DURING SURGERY AND FRACTURING AS IT WAS IMPLANTED. USED ANOTHER DEVICE TO COMPLETE THE CASE. NO SURGICAL DELAY OR PATIENT HARM. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25427398 ↗MalfunctionJun 3, 2026Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE BROKE. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25377135 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT DURING ARTHROSCOPY SURGERY, THE HEALIX ADVANCE BR ANCHOR W/DYNACORD ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016540 ↗MalfunctionApr 27, 2026Break
IT WAS REPORTED FROM A HEALTH AUTHORITY THAT DURING THE ROTATOR CUFF REPAIR SURGERY WITH A 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE, THE ANCHOR BROKE. THEY REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24996784 ↗MalfunctionApr 24, 2026Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, WHILE USING THE 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE, IT WAS OBSERVED THAT THE ANCHOR WAS BROKEN OFF. IT WAS REPORTED THAT THE SURGEON CHANGED TO ANOTHER 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24988398 ↗MalfunctionApr 22, 2026Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HEALIX ADVANCE BR ANCHOR DEVICE BROKE OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 24956271 ↗MalfunctionApr 20, 2026Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED 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 24926654 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE TIP OF THE HEALIX ADVANCE BR ANCHOR W/DYNACORD ANCHOR WAS BROKEN. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24696850 ↗MalfunctionMar 12, 2026Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE 4.5HLX ADV BR ANC-DYNA STR/BL ANCHOR DEVICE WHEN TIGHTENED THE SUTURE, THE SUTURE BROKE OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583073 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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