HEALIX ADVANCE 222582Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886705030316), received between Feb 28, 2019 and Jan 31, 2024 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOLD FOR RW 1.31 THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH TEAM THAT DURING AN ACHILLES TENDON REPAIR PROCEDURE ON (B)(6) 2023, A 5.5 HEALIX ADVANCE KNTLS BR DEVICE WAS USED. ACCORDING TO THE REPORT, THE PATIENT HAD FOREIGN BODY REACTION/OSTEOLYSIS POSTOPERATIVELY ON (B)(6) 2024. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body Reaction; Osteolysis

  MAUDE report 18618950 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CLINICAL RESEARCH TEAM THAT AFTER A ROTATOR CUFF REPAIR PROCEDURE ON THE RIGHT SIDE ON (B)(6) 2022, IT WAS OBSERVED THAT THE PATIENT EXPERIENCED RE-TEARS OR NEW TEARS. THE SURGERY OCCURRED ON (B)(6) 2022 USING A 5.5 HEALIX ADVANCE DEVICE AND A 4.75 HEALIX ADVANCE BR DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18268883 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CLINICAL RESEARCH TEAM THAT AFTER ROTATOR CUFF REPAIR ON (B)(6) 2023 THE PATIENT EXPERIENCED ACUTE HYPOXEMIC RESPIRATORY FAILURE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Respiratory Failure

  MAUDE report 17948708 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A RIGHT ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, THE 4.75 HEALIX ADVANCE KNTLS BR DEVICE, 5.5 HEALIX ADVANCE KNTLS BR, 4.5HLX ADV BR ANC-DYNA 3-SUT DEVICES WERE BEING USED WHEN THE PATIENT EXPERIENCED RE-TEARS OR NEW TEARS POST OPERATIVELY. IT WAS REPORTED THAT THIS RESULTED IN THE PATIENT REQUIRING A RE-OPERATION/REVISION PROCEDURE. IT WAS RECOMMENDED A RIGHT SHOULDER TISSUE AND CULTURE ACQUISITION, REVERSE TOTAL SHOULDER ARTHROPLASTY AND POSSIBLE BICEPS TENODESIS BE PERFORMED. IT WAS REPORTED THAT THIS EVENT OCCURRED AS A PART OF A CLINICAL TRIAL. IT WAS REPORTED THAT THE SEVERITY WAS SEVERE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17930077 ↗
• MalfunctionJul 26, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE KNOTLESSS BR DEVICE KEPT SPINNING IN PLACE AND WOULDN¿T BITE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A TWO MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397407 ↗
• MalfunctionMay 10, 2022Crack; Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14344880 ↗
• MalfunctionOct 27, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE KNTLS BR DEVICE 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 12706293 ↗
• MalfunctionOct 27, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE KNTLS BR DEVICE 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 12706239 ↗
• MalfunctionMar 25, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANCHOR DEVICE 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 11569902 ↗
• MalfunctionDec 22, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE KNTLS BR DEVICE BROKE WHILE TRYING TO PLACE THE SUTURE THROUGH IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO SURGICAL DELAY, OR PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11055052 ↗
• MalfunctionJan 29, 2020Crack; Crack

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE WHEN LOADING THE SUTURES ONTO TWO OF THE CUSTOMER'S 5.5 HEALIX ADVANCE KNOTLESS BR ANCHORS AND PULLING THE SUTURES THROUGH, THE TIPS OF BOTH DEVICES CRACKED. THE DEVICES WERE NEVER IMPLANTED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT HARM BUT THERE WAS A 10 MINUTE SURGICAL DELAY TO THE CASE. THE DEVICES WERE DISCARDED.

  Patient problems: Not Applicable

  MAUDE report 9643077 ↗
• MalfunctionJan 29, 2020Crack; Crack

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE WHEN LOADING THE SUTURES ONTO TWO OF THE CUSTOMER'S 5.5 HEALIX ADVANCE KNOTLESS BR ANCHORS AND PULLING THE SUTURES THROUGH, THE TIPS OF BOTH DEVICES CRACKED. THE DEVICES WERE NEVER IMPLANTED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT HARM BUT THERE WAS A 10 MINUTE SURGICAL DELAY TO THE CASE. THE DEVICES WERE DISCARDED.

  Patient problems: Not Applicable

  MAUDE report 9642941 ↗
• MalfunctionNov 25, 2019Break; Break

  THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THE HEALIX ADVANCE KNTLS BR BROKE FROM SUTURES PASSING THROUGH THE ANCHOR. ACCORDING TO THE REPORT, THE EVENT OCCURRED WHEN USING THE DOUBLE KITE PASSING DYNACORD THOUGHT THE ANCHORS. THE PROCEDURE WAS DELAYED BY FIVE MINUTES. ANOTHER ANCHOR WAS OPENED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE ANCHORS BROKE BEFORE INSERTION AND THEY NEVER ENTERED THE PATIENT. THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2019. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 9369711 ↗
• MalfunctionNov 25, 2019Break; Break

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THE HEALIX ADVANCE KNTLS BR BROKE FROM SUTURES PASSING THROUGH THE ANCHOR. ACCORDING TO THE REPORT, THE EVENT OCCURRED WHEN USING THE DOUBLE KITE PASSING DYNACORD THOUGHT THE ANCHORS. THE PROCEDURE WAS DELAYED BY FIVE MINUTES. ANOTHER ANCHOR WAS OPENED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE ANCHORS BROKE BEFORE INSERTION AND THEY NEVER ENTERED THE PATIENT. THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2019. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 9369706 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE CUSTOMER'S 5.5 HEALIX ADVANCE KNOTLESS ANCHOR WAS BROKEN INSIDE THE PACKAGING. THE ANCHOR WAS NOT USED ON THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER LIKE-ANCHOR WITH NO PATIENT HARM OR DELAY. THE SALES REP WAS NOT PRESENT AND COULD NOT SPECIFY HOW THE ANCHOR WAS BROKEN INSIDE THE PACKAGE OR ANY ADDITIONAL INFORMATION. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125452 ↗
• MalfunctionSep 4, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE TIP OF THE CUSTOMER'S 5.5 HEALIX ADVANCE KNOTLESS BR ANCHOR BROKE WHEN THE SURGEON TRIED TO PULL THE SUTURES THROUGH THE DEVICE. THE SALES REP STATED THAT THE DEVICE WAS NEVER IMPLANTED IN THE PATIENT WHEN THE ISSUE OCCURRED THEREFORE NO DEBRIS IN PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP STATED THAT THE CUSTOMER DISCARDED THE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8962907 ↗
• MalfunctionAug 27, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED BY THE SALES REP VIA CST TOOL THAT DURING A ROTATOR CUFF REPAIR PROCEDURE TWO OF THE CUSTOMER'S 4.75 HEALIX ADVANCE KNOTLESS BR ANCHORS AND ONE OF 5.5 HEALIX ADVANCE KNOTLESS BR ANCHOR THAT DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY OR PATENT CONSEQUENCES. THERE WAS NO FRAGMENTS GENERATED. FURTHER IT WAS REPORTED BY THE SALES REP THAT THE ANCHORS WOULD NOT ADVANCE. THE SALES REP STATED THAT THE PATIENT HAD VERY BAD BONE QUALITY. THE PROCEDURE WAS COMPLETED USING THE SAME BONE HOLE WITH A COMPETITOR'S DEVICE. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES AS THEY WERE DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8936315 ↗
• MalfunctionMay 30, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE CUSTOMER'S 5.5 HEALIX ADVANCE KNOTLESS ANCHOR WAS BEING PULLED THROUGH THE SYSTEM WHEN THE TIP OF THE ANCHOR BROKE. THE ANCHOR BROKE PRIOR TO INSERTION INTO THE PATIENT. THE SALES REP STATED THAT THERE WERE THREE SUTURES OF ORTHOCORD WITH SIX TAILS THAT WERE EQUAL IN LENGTH AND WERE NOT TANGLED. THE ANCHOR WAS REMOVED FROM THE SYSTEM AND ANOTHER LIKE-ANCHOR WAS USED TO COMPLETE THE CASE WITHOUT PATIENT HARM OR SURGICAL DELAY. THE ANCHOR WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8653458 ↗
• MalfunctionMay 14, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE SUTURE BRIDGE OF THE SALES REP'S 5.5 HEALIX ADVANCE KNOTLESS ANCHOR BROKE DURING INSERTION. THE SALES REP STATED THAT THE ANCHOR WAS NOT FULLY IN THE PATIENT'S CAVITY WHEN THE SUTURE BRIDGE BROKE. THE ANCHOR WAS BEING USED WITH A 5.5 HEALIX ADVANCE AWL AND HAD TWO TAILS OF DYNACORD. THE CASE WAS COMPLETED WITH ANOTHER LIKE-ANCHOR IN THE SAME BONE HOLE WITH NO PATIENT HARM OR DELAY. THE ANCHOR WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609345 ↗
• MalfunctionFeb 28, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE SALES REP'S 5.5 HEALIX ADVANCE KNOTLESS ANCHOR TIP BROKE WHILE TRYING TO PULL THE ANCHOR THROUGH THE SYSTEM. THE SALES REP STATED THE BREAKAGE OCCURRED OUTSIDE OF THE PATIENT AND THE ANCHOR WAS REMOVED BY PULLING ON THE SUTURES. THE SALES REP STATED THERE WERE THREE ORTHOCORD SUTURES WITH SIX TAILS THAT WERE EQUAL IN LENGTH AND THEY WERE NOT TANGLED. THE CASE WAS COMPLETED WITH ANOTHER LIKE-ANCHOR WITH NO PATIENT HARM, BUT A ONE MINUTE DELAY TO OBTAIN THE NEW ANCHOR. THE DEVICE IS BEING RETURNED FOR EVALUATION. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE ON 02/22/19 REPORTED THAT THE IMPLANT WAS BROKEN IN ONE PLACE ON THE ANCHOR. IT WAS ALSO REPORTED THAT THE PATIENT'S BONE QUALITY WAS GOOD, THE SURGEON WAS NOT OFF AXIS, AND THAT THE SAME BONE HOLE WAS USED TO INSERT THE ALTERNATIVE IMPLANT. THE AFFILIATE STATED THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT BECAUSE THE IMPLANT BROKE OUTSIDE THE PATIENT. THE AFFILIATE STATED THAT THE SUTURES WERE DETACHED FROM THE RING CLEATS AND THE STAY SUTURE WAS REMOVED.

  Patient problems: Not Applicable

  MAUDE report 8379082 ↗