HEALIX ADVANCE 222584Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705030330), received between Nov 14, 2019 and Mar 17, 2026 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Break

  IT WAS REPORTED THAT THE 4.75 HEALIX ADVANCE KNTLS PEEK ANCHOR DEVICE BROKE DURING INSERTION. IT WAS REPORTED THAT ANOTHER DEVICE WAS OPENED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SURGEON DID NOT NEED TO CREATE ANOTHER HOLE. IT WAS REPORTED THAT THERE WAS A 2-MINUTE DELAY DUE TO OPENING THE NEW DEVICE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619774 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 4 OF 4 FOR (B)(4). IT WAS REPORTED THROUGH A POST MARKET CLINICAL RESEARCH STUDY THAT A PATIENT HAD UNDERGONE AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION WITH MENISCAL REPAIR PROCEDURE ON (B)(6) 2024, USING A MILAGRO ADVANCE SCREW 10X23MM DEVICE, A RGDLOOP ADJUSTABLE LONG, A TRUESPAN 12 DEGREE PEEK DEVICE AND A 4.75 HEALIX ADVANCE KNTLS PEEK DEVICE. ACCORDING TO THE REPORT, THE PATIENT HAD A RETEAR OF HIS RECONSTRUCTED ACL RESULTING IN RE-OPERATION/REVISION WHERE ALL OF THE INITIAL HARDWARE WAS REMOVED AND REVISED. THERE WERE NO REPORTS OF DELAY IN THE PROCEDURE REPORTED. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20835125 ↗
• MalfunctionMay 23, 2024Break; Crack; Break; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 2X 4580 FMS DUO+ PUMP/SHAVER DEVICE HAD CRACKS IN BOTH ANCHOR BODIES BEFORE THE USER TRIED TO INSERT THEM. DESPITE NOTICING THE CRACK THE SURGEON TRIED TO IMPLANT THE FIRST ANCHOR AND IT BROKE AS IT WAS GOING IN. HE REFUSED TO TRY IMPLANTING THE SECOND ANCHOR AFTER DISCOVERING IT WAS ALSO CRACKED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIFTEEN MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382272 ↗
• MalfunctionMay 23, 2024Break; Crack; Break; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 2X 4580 FMS DUO+ PUMP/SHAVER DEVICE HAD CRACKS IN BOTH ANCHOR BODIES BEFORE THE USER TRIED TO INSERT THEM. DESPITE NOTICING THE CRACK THE SURGEON TRIED TO IMPLANT THE FIRST ANCHOR AND IT BROKE AS IT WAS GOING IN. HE REFUSED TO TRY IMPLANTING THE SECOND ANCHOR AFTER DISCOVERING IT WAS ALSO CRACKED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIFTEEN MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS EVENT 1 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382248 ↗
• MalfunctionApr 2, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED BY THE SALES REP THAT PRIOR TO A PATELLAR TENDON REPAIR PROCEDURE, IT WAS NOTED THAT UPON OPENING THE 4.75 HEALIX ADVANCE KNOTLESS PEEK DEVICE, A 4.5 HEALIX ADVANCE MEDIAL ROW ANCHOR WAS FOUND IN THE PACKAGING. THE SURGERY WAS RESOLVED BY PASSING THREADED SUTURE THROUGH BEATH PIN. IT WAS REPORTED THAT THERE WAS A TWO-MINUTE DELAY TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19023810 ↗
• InjuryMar 31, 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 REVIEW OF A CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF 4.75 HEALIX ADVANCE KNTLS PEEK DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REOPERATION 77 DAYS AFTER THE INITIAL PROCEDURE DUE TO STIFFNESS THAT INCLUDED CAPSULAR RELEASE MANIPULATION UNDER ANESTHESIA. ACCORDING TO THE REPORT, THE PATIENT HAD JOINT STIFFNESS 40 DAYS AFTER THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Loss of Range of Motion; Unspecified Tissue Injury

  MAUDE report 13969639 ↗
• InjuryMar 31, 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 REVIEW OF A CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF 4.75 HEALIX ADVANCE KNTLS PEEK DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2019, A PATIENT HAD A REOPERATION 315 DAYS FROM THE INITIAL PROCEDURE THAT INCLUDED A RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY AS THE HEALING AND FUNCTIONAL OUTCOME WERE NOT GOING WELL. ACCORDING TO THE REPORT, THE PATIENT HAD JOINT STIFFNESS 128 DAYS FROM THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Loss of Range of Motion; Unspecified Tissue Injury

  MAUDE report 13969247 ↗
• MalfunctionDec 29, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE SUTURES OF THE 4.75 HEALIX ADVANCE KNOTLESS PEEK DEVICE DID NOT COME THROUGH WHILE PULLING THEM. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11087634 ↗
• MalfunctionNov 4, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING A ROTATOR CUFF REPAIR THE SUTURES OF THE 4.75 HEALIX ADVANCE KNOTLESS PEEK DID NOT PASS THROUGH THE ANCHORS. THEY GOT HELD UP IN THE NOSE DURING SUTURE PASSAGE. SUTURES WERE CUT AND A SECOND ANCHOR WAS USED. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE WAS DISCARDED BY THE STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10788174 ↗
• MalfunctionJun 24, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE 4.75 HEALIX ADVANCE KNOTLESS PEEK PHYSICALLY BROKE DURING INSERTION. NO FRAGMENTS WERE GENERATED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10190940 ↗
• InjuryNov 20, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE DYNACORD SUTURES GOT STUCK IN THEIR 4.75 HEALIX ADVANCE KNOTLESS ANCHOR AS THEY WERE BEING PULLED THROUGH THE ANCHOR THREADED TAB BROKE. IT WAS REPORTED THAT THEY NEVER WERE ABLE TO SLIDE THE ANCHOR DOWN THE CANNULA. IT WAS REPORTED THAT THEY WEREN¿T ABLE TO GET THE SUTURES TO PASS THROUGH THE ANCHOR. IT WAS REPORTED THAT NOTHING WAS LEFT IN THE PATIENT. WE USED THE HOLE WE PUNCHED WITH THE SECOND ANCHOR. THE PROCEDURE WAS COMPLETED BY CUTTING THE SUTURE, AND LOADING UP A NEW ANCHOR. THERE WAS NO PATIENT CONSEQUENCES OR SURGICAL DELAY TO THE CASE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 9349399 ↗
• MalfunctionNov 14, 2019Crack; Crack

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2019, THE TIP OF THEIR 5.5MM HEALIX ADVANCE BR ANCHOR WITH DYNACORD SUTURE CRACKED DURING INSERTION BUT DID NOT BREAK INTO TWO PLUS PIECE WAS STILL INTACT. ALSO, IN THE SAME CASE THE TIP OF THEIR 4.75 HEALIX ADVANCE KNOTLESS PEEK ANCHOR CRACKED WHEN PULLING THE SUTURES THROUGH WHICH OCCURRED OUTSIDE THE PATIENT. NO DEBRIS WAS CREATED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH OTHER LIKE DEVICES USING THE SAME BONE HOLE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE PATIENT'S BONE QUALITY WAS HARD. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9323826 ↗