HEALIX ADVANCE DYNATAPE DYNACORDRecalls & reported problems across all models

We found 7 models of HEALIX ADVANCE DYNATAPE DYNACORD by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Feb 25, 2022 and Apr 6, 2026 — classified as 8 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 DYNATAPE DYNACORD problems

HEALIX ADVANCE DYNATAPE DYNACORD models

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

• HEALIX ADVANCE DYNATAPE DYNACORD 280723

  Fastener, fixation, biodegradable, soft tissue
  10 reports
• HEALIX ADVANCE DYNATAPE DYNACORD 280735

  Fastener, fixation, biodegradable, soft tissue
  8 reports
• HEALIX ADVANCE DYNATAPE DYNACORD 280729

  Screw, fixation, bone
  4 reports
• HEALIX ADVANCE DYNATAPE DYNACORD 280717

  Screw, fixation, bone
  4 reports
• HEALIX ADVANCE DYNATAPE DYNACORD 280736

  Fastener, fixation, biodegradable, soft tissue
  1 report
• HEALIX ADVANCE DYNATAPE DYNACORD 280724

  Fastener, fixation, biodegradable, soft tissue
  1 report
• HEALIX ADVANCE DYNATAPE DYNACORD 280718

  Screw, fixation, bone
  1 report

Recent HEALIX ADVANCE DYNATAPE DYNACORD adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE 4.5 HLX ADV BR 2.5 DYNAT BLK ANCHOR DEVICE COULD NOT BE INSERTED BECAUSE IT DID NOT ROTATE PROPERLY DURING INSERTION. 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 24794593 ↗
• MalfunctionFeb 20, 2026Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THAT THE 4.5 HLX ADV PK 2.5 DYNAT WHAT ANCHOR DEVICE INSERTER WAS STRIPPED INSIDE THE IMPLANT. 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 24405542 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT AFTER CREATING A BONE HOLE WITH AN AWL, THE ANCHOR ON THE 4.5 HLX ADV BR 2.5 DYNAT WHT DEVICE WAS INSERTED, BUT THE ANCHOR BROKE. THE REPORTER INDICATED THAT IT WAS POSSIBLE THAT THE PATIENT'S BONE WAS TOO HARD, BUT SINCE THE SUBSEQUENT ANCHOR DID NOT BREAK, A PRODUCT ISSUE WAS SUSPECTED. 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 22983252 ↗
• MalfunctionMay 16, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE FOR A SHOULDER ROTATOR CUFF TEAR, THE 4.5 HLX ADV BR 2.5 DYNAT BLK DEVICE WAS USED AS THE MEDIAL ANCHOR. HOWEVER, WHEN ATTEMPTING TO INSERT THE ANCHOR, THE THREADS OF THE INSERTER AND THE ANCHOR DID NOT MESH WELL, MAKING IT UNUSABLE. 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 22036053 ↗
• MalfunctionMar 24, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF TEAR SURGICAL PROCEDURE, WHEN THE SURGEON INSERTED THE 4.5 HLX ADV BR 2.5 DYNAT BLK ANCHOR DEVICE INTO THE PATIENT¿S BODY UNDER AN ARTHROSCOPE, HE FOUND THAT THE DEVICE HAD CRACKED. IT WAS REPORTED THAT THE DEFECTIVE DEVICE WAS REMOVED IMMEDIATELY. ANOTHER DEVICE WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 21680393 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON THE RIGHT SHOULDER FOR A SHOULDER ROTATOR CUFF TEAR, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5 HLX ADV BR 2.5 DYNAT WHT DEVICE BROKE. IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO INSERT THE DEVICE AFTER CREATING THE BONE HOLE BUT DISCONTINUED ITS USE WHEN THE ANCHOR PORTION BROKE IN A SPIRAL SHAPE. NO FRAGMENTS OF THE DAMAGED IMPLANT WERE LEFT IN THE BODY. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 20824788 ↗
• MalfunctionNov 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROXIMAL HAMSTRING REPAIR SURGICAL PROCEDURE, THE FOUR 4.5 HLX ADV PK 2.5 DYNAT BLK DEVICES WERE BEING INSERTED INTO THE BONE. AS THE SURGEON WAS PASSING THE DYNATAPE SUTURE TO THE TENDON THE DYNATAPE DEVICE FELL OUT OF THE ANCHOR. THE ANCHOR ALSO LEFT IMPACT IN THE BONE AND DID NOT BREAK. ANOTHER DYNATAPE SUTURE ALSO IMPACTED ON THE ANCHOR. THE ANCHOR WAS STILL SUCCESSFULLY FIXATED WITH THE DYNACORD SUTURE STILL IN THE ANCHOR. IT WAS THE DYNATAPE THAT FAILED. THERE WAS AN UNSPECIFIED SURGICAL DELAY HOWEVER IT WAS NOT DUE TO THE ANCHOR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736984 ↗
• MalfunctionNov 7, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4.5 MM HEALIX ADVANCE TM BR ANCHOR WITH (1) 2.5 MM DYNATAPE TM IN WHITE/ BLACK AND (1) #2 DYNACORD TM IN BLUE, WITH UTILITY SHUTTLE SUTURE NO NEEDLES, BROKE MULTIPLE TIMES. 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 18084278 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2023 WHILE USING THE 4.5 HLX ADV BR 2.5 DYNAT BLK DEVICE THE SURGEON PUNCHED THE HOLE FOR 4.5 MM HEALIX ADVANCE TM BR ANCHOR WITH (1) 2.5 MM DYNATAPE TM IN BLACK/BLUE AND (1) #2 DYNACORD TM IN WHITE/BLUE/GREEN, WITH UTILITY SHUTTLE SUTURE, NO NEEDLES AND THE TIP OF THE ANCHOR BROKE EVEN THOUGH THE SURGEON SUGGESTED THE BONE WAS NOT HARD. NEW ANCHOR WAS OPENED AND IT WAS IMPLANTED SUCCESSFULLY. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011699 ↗
• MalfunctionJul 26, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE INTERNAL PART OF THE 4.5 MM HEALIX ADVANCE TM BR ANCHOR WITH (1) 2.5 MM DYNATAPE TM IN BLACK/BLUE AND (1) #2 DYNACORD TM IN WHITE/BLUE/GREEN, WITH UTILITY SHUTTLE SUTURE, NO NEEDLES DEVICE THAT HELD THE SUTURES BROKE AFTER PASSING THE SUTURES AND TYING OVER THE CUFF. ACCORDING TO THE REPORT, THE ANCHOR BODY REMAINED LODGED IN THE HUMERAL HEAD WHILE THE SUTURES REMAINED IN THE CUFF. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17399319 ↗
• MalfunctionJul 10, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE OF THE LEFT SHOULDER ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4.5 HLX ADV BR 2.5 DYNAT BLK DEVICE BROKE OFF. REMOVED ALL THE BROKEN PARTS. 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 17289296 ↗
• MalfunctionMay 23, 2023Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING A LATERAL ANKLE STABILZATION PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE DISTAL TIP ON THE HEALIX ADVANCE PEEK ANCHOR W/ DYNATAPE SUTURE WITH (1) 2.5MM BLACK/BLUE DEVICE CRACKED UPON INSERTION. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 16987309 ↗
• MalfunctionMay 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT DURING A ROTATOR CUFF REPAIR PROCEDURE OF THE LEFT SHOULDER ON (B)(6) 2022, IT WAS OBSERVED THAT THE HEALIX ADVANCE BR ANCHOR W/ DYNATAPE SUTURE TCP/PLGA ABSORBABLE ANCHOR WITH (1) 2.5MM WHITE/BLACK DY DEVICE PULLED THROUGH THE ANCHOR. 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 16979270 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL TRIAL THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE ON THE RIGHT SHOULDER INITIALLY PERFORMED ON (B)(6) 2022 USING A HEALIX ADVANCE DYNATAPE DYNACORD, A PATIENT HAD A REOPERATION PROCEDURE ON (B)(6) 2022 DUE TO JOINT STIFFNESS.

  Patient problems: Loss of Range of Motion

  MAUDE report 16472221 ↗
• MalfunctionDec 30, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4.5 MM HEALIX ADVANCE TM BR ANCHOR WITH (1) 2.5 MM DYNATAPE TM IN WHITE/ BLACK AND (1) #2 DYNACORD TM IN BLUE, WITH UTILITY SHUTTLE SUTURE, NO NEEDLES 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 16080573 ↗

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