HEALIX ADVANCE BR ANCHOR w/DYNACORD 222004Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705029464), received between Jun 27, 2018 and Jul 23, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: RE-TEARS OR NEW TEARS [POST-OPERATIVE]. OPERATIVE SIDE: RIGHT. WAS THE FMS VUE II SYSTEM USED FOR THIS PROCEDURE?: YES, WAS THE VAPR SYSTEM USED FOR THIS PROCEDURE?: YES, WAS THE SPEEDTRAP GRAFT PREPARATION SYSTEM USED FOR THIS PROCEDURE?: NO. IF THE START DATE IS EQUAL TO THE DATE OF PROCEDURE, WHEN DID THE EVENT OCCUR?: BLANK. SEVERITY: MODERATE. DID THIS EVENT RESULT IN A RE-OPERATION/REVISION? IF YES, COMPLETE THE RE-OPERATION/REVISION FORM.: YES, HAS IMPLANT CAUSED OR CONTRIBUTED TO DEATH OR SERIOUS INJURY TO THE PATIENT?: NO.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22575309 ↗
• MalfunctionOct 11, 2023Crack; Crack

  IT WAS REPORTED BY SALES REP VIA EMAIL THAT DURING ROTATOR CUFF REPAIR BODY OF THE 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE AND WHITE/BLUE/GREEN) CRACKED AFTER THE FIRST TWIST, NOT WORKING ON HARD BONE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912937 ↗
• MalfunctionJun 12, 2023Migration; Migration

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE AND WHITE/BLUE/GREEN) DEVICE HAD NO FIXATION AND PULLED OUT OF THE PATIENT'S BONE IMMEDIATELY. ACCORDING TO THE REPORT, THE PHYSICIAN UPSIZED TO A 6.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE AND WHITE/BLUE/GREEN) DEVICE BUT PULLED AS WELL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A FIVE MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17110047 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH A CLINICAL TRIAL USING 5.5HLX ADV BR ANC-DYNA STR/BL DEVICE THAT A PATIENT HAD NEUROVASCULAR INJURY RELATED TO A BICEPS TENODESIS PROCEDURE OF THE LEFT SHOULDER THAT WAS PERFORMED ON (B)(6) 2021. ACCORDING TO THE REPORT, THE PATIENT CONSEQUENCE WAS MILD; AND THEREFORE, DID NOT REQUIRE A REVISION/REOPERATION PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Nerve Damage; Perforation of Vessels

  MAUDE report 13598878 ↗
• InjurySep 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE THREADS ON THE 5.5HLX ADV BR ANC-DYNA STR/BL DEVICE PULLED OFF ONCE IMPACTED. THE SURGEON COULD NOT RECOVERED THE ANCHOR AND HAD TO USE A NEW ANCHOR TO FINISH THE PROCEDURE. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12446444 ↗
• MalfunctionSep 9, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A BICEP TENODESIS PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5HLX ADV BR ANC-DYNA STR/BL DEVICE BROKE UPON INSERTION AS IT WAS TAP INTO THE BONE HOLE. 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 12446413 ↗
• InjuryNov 1, 2019Break; Break

  IT WAS REPORTED VIA PHONE THAT THE SUTURE BRIDGE OF THE 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE AND WHITE/BLUE/GREEN) BROKE. THIS DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE STATED THE REPORTED FAILURE OCCURRED INTRA-OP AND A SURGICAL DELAY DID NOT OCCUR. THE AFFILIATE ALSO REPORTED THAT FRAGMENTS WERE NOT GENERATED BUT A PART OF THE DEVICE REMAINED IN THE PATIENT. IT WAS ALSO REPORTED THE PROCEDURE WAS COMPLETED WITH A READILY AVAILABLE ANCHOR AND SURGICAL INTERVENTION IS NOT PLANNED. THERE WERE NO REPORTED CONSEQUENCES TO THE USER OR PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9268001 ↗
• MalfunctionJun 27, 2018Break; Break

  IT WAS REPORTED VIA EMAIL THAT A DOCTOR EXPERIENCED AN ISSUE A DYNACORD BREAK. AFTER FOLLOWING UP WITH THE SALES REP VIA PHONE, HE STATED THAT DURING A ROTATOR CUFF PROCEDURE WHILE THE DOCTOR WAS TYING THE HALF HITCH KNOT, THE DYNACORD BROKE. HE DID NOT THINK IT NEEDED TO BE REPORTED SINCE THE BREAK WAS WHERE THE DOCTOR WAS GOING TO CUT THE SUTURE IN THE END. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7642471 ↗