HEALIX ADVANCE BR 3 SUTURE ANCHOR w/DYNACORDRecalls & reported problems across all models

We found 2 models of HEALIX ADVANCE BR 3 SUTURE ANCHOR w/DYNACORD by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 72 adverse event reports in the FDA's MAUDE database, received between Dec 28, 2018 and Aug 19, 2026 — classified as 24 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Break” (33 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 BR 3 SUTURE ANCHOR w/DYNACORD problems

HEALIX ADVANCE BR 3 SUTURE ANCHOR w/DYNACORD models

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

• HEALIX ADVANCE BR 3 SUTURE ANCHOR w/DYNACORD 222002

  Fastener, fixation, biodegradable, soft tissue
  49 reports
• HEALIX ADVANCE BR 3 SUTURE ANCHOR w/DYNACORD 222005

  Fastener, fixation, biodegradable, soft tissue
  23 reports

Recent HEALIX ADVANCE BR 3 SUTURE 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.

• MalfunctionAug 19, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50330325 ↗
• MalfunctionJun 9, 2026Unintended Movement

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE HEALIX ADVANCE BR 3 SUTURE ANCHOR W/DYNACORD DEVICE, AT THE KNOT, THE BLACK AND WHITE THREAD IS LOOSENED. THE BLUE-WHITE THREADS AND THE BLUE THREADS HELD FIRMLY IN THE ANCHOR, ONLY THE ONE PAIR OF THREADS HAD COME LOOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. SURGERY WAS COMPLETED NORMALLY. 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 25441944 ↗
• MalfunctionApr 27, 2026Migration

  IT WAS REPORTED THAT DURING PATELLAR DISLOCATION SURGERY, THE HEALIX PEEK ORTHOCORD ANCHOR PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A FIVE MINUTE DELAY. THERE WERE NO ADDITIONAL ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25004257 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR PROCEDURE, THE 5.5HLX ADV BRANC-DYNA 3-SUT DEVICE BROKE. 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 24283831 ↗
• MalfunctionJan 30, 2026Migration

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE 5.5HLX ADV BR ANC-DYNA 3-SUT DEVICE, AFTER THE SURGEON DEPLOYED THE ANCHOR, THE ANCHOR CAME OUT OF THE BONE FORAMEN WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE PIECES LEFT IN THE BODY. 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 24222115 ↗
• MalfunctionOct 23, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5HLX ADV BR ANC-DYNA 3-SUT DEVICE ANCHOR WAS CRACKED AND BECAME UNUSABLE. 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 23367391 ↗
• MalfunctionOct 15, 2025Crack; Crack

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE NOSE IN THE PUNCH HOLE CAUSED THE ANCHOR CRAFT ON THE 5.5HLX ADV BR ANC-DYNA 3-SUT DEVICE TO CRACK IMMEDIATELY. IT WAS CLEARLY DAMAGED BEFOREHAND, AND EVEN TWISTING THE ANCHOR TO SCREW IT IN CAUSED IT TO CRACK. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 23279265 ↗
• MalfunctionJul 10, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE ANCHOR OF THE 4.5HLX ADV BR ANC-DYNA 3-SUT DEVICE WAS FOUND TO HAVE MIGRATED. IT WAS REPORTED THAT WHILE THE SURGEON WAS IMPLANTING THE DEVICE, AFTER THE SCREW WAS INSERTED, THE HANDLE CAME OUT TOGETHER WITH ALL THE SUTURES WHILE THE SCREW WAS SECURELY FIXED. A SMOOTH AWL WAS USED PRIOR TO IMPLANTATION, AND OBSERVATIONS OF THE SURGEON INDICATED NO ODD ANGLES OR DIFFICULTIES DURING THE SCREW INSERTION. THERE WAS A FIVE-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473123 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS IT WAS OBSERVED THAT WHEN THE 4.5HLX ADV BR ANC-DYNA 3-SUT ANCHOR DEVICE WAS DRIVEN IN BY HITTING, THE METAL PART BROKE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22154434 ↗
• MalfunctionMay 6, 2025Break; Crack; Noise, Audible; Break; Crack; Noise, Audible

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF TEAR SURGICAL PROCEDURE FOR A ROTATOR CUFF TEAR ON THE SHOULDER, WHILE USING THE 4.5HLX ADV BR ANC-DYNA 3-SUT DEVICE A BONE HOLE WAS CREATED WITH AN AWL AS USUAL AND THE ANCHOR WAS INSERTED, BUT PART WAY THROUGH THE SURGEON NOTICED AN ABNORMAL NOISE AND WHEN HE CHECKED THE ANCHOR IT WAS CRACKED AND THE ANCHOR PART WAS BROKEN. HE HAD THE ANCHOR REMOVED IN THE REVERSE DIRECTION AND ALL OF THE ANCHOR WAS RETRIEVED. THE ANCHOR WAS SUCCESSFULLY INSERTED AND SUTURED USING AS SPARE DEVICE. THERE WAS A THIRTY MINUTE DELAY TO THE PROCEDURE. 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 21971058 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN ROTATOR CUFF REPAIR (ORCR) PROCEDURE ON THE SHOULDER, WHEN THE SURGEON MADE A BONE HOLE AND TRIED TO INSERT THE 5.5HLX ADV BR ANC-DYNA 3-SUT ANCHOR DEVICE IT WAS OBSERVED THAT THE TIP OF THE DEVICE BROKE. IT WAS REPORTED THAT THERE WAS NO RESIDUE OF THE DEVICE LEFT IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942004 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF REPAIR (ARCR) PROCEDURE FOR A ROTATOR CUFF TEAR, IT WAS OBSERVED THAT EVEN THOUGH THE 4.5HLX ADV BR ANC-DYNA 3-SUT ANCHOR DEVICE WAS INSERTED AT THE CORRECT ANGLE, IT BROKE. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891665 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT DURING ANTERIOR ROTATOR CUFF REPAIR SURGICAL PROCEDURE THE 5.5HLX ADV BR ANC-DYNA 3-SUT DEVICE WHEN INSERTED THE PRODUCT IN QUESTION AFTER CREATING THE BONE HOLE. HOWEVER, DURING INSERTION, THE ANCHOR CRACKED AND BROKE. ALL DAMAGED ANCHORS WERE RECOVERED. THE NEW PRODUCT WAS OPENED AND USED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379003 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5HLX ADV BR ANC-DYNA 3-SUT DEVICE BROKE OFF DURING INSERTION. ACCORDING TO THE REPORTER, THE SURGEON CONDUCTED A HALF TAP AND THEN A FULL TAP ON THE GREATER TUBEROSITY BEFORE INSERTING THE DEVICE. HOWEVER, THE ANCHOR BROKE OFF DURING THE INSERTION. THE SURGEON THEN SWITCHED TO A FULL TAP, REINSERTED THE DEVICE, AND SUCCESSFULLY DEPLOYED THE ANCHOR. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 21375688 ↗
• MalfunctionJan 15, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5HLX ADV BR ANC-DYNA 3-SUT SUTURE DEVICE RIPPED THROUGH THE EYELET OF THE ANCHOR AFTER IMPLANTATION. IT WAS REPORTED THAT THERE WERE FRAGMENTS GENERATED AND WERE EASILY REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, AND NO SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162556 ↗

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