HEALIX ADVANCE BR ANCHOR w/PERMATAPE PERMACORD 222362Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705027828), received between Sep 21, 2018 and Sep 13, 2024 — classified as 2 injuries, 6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2024Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP FROM JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) PROCEDURE THE HEALIX AV BR 5.5 TAPE WHT/BLUE ANCHOR DEVICE WAS DEPLOYED IN THE HUMERAL HEAD IN A SPECULAR ROTATOR CUFF SUTURE. AFTER COMPLETING THE SUTURE BY APPLYING THE ATTACHED THREAD TO THE ROTATOR CUFF, THE SURGEON CHECKED THE INSIDE OF THE JOINT AND FOUND THAT THE ANCHOR WAS NOT FULLY DEPLOYED, AND THE ANCHOR PORTION HAD PROTRUDED THROUGH THE BONY FORAMEN. SINCE THE ROTATOR CUFF HAD ALREADY BEEN SUTURED, THE DOCTOR DECIDED TO FOLLOW UP THE PATIENT'S CONDITION. 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 20213824 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 6 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, A 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, WHITE/BLUE DEVICE WAS USED. ACCORDING TO THE REPORT, THE MRI THREE MONTHS AFTER SURGERY SHOWED EDEMA AROUND THE ANCHOR AND THE ANCHOR TIP. IT WAS REPORTED THAT ON (B)(6) 2023, POSTOPERATIVE MRI SHOWED SYMPTOMS THAT SUGGEST EDEMA OR BONE RESORPTION IN THE HUMERUS WHERE THE ANCHOR IN QUESTION WAS DEPLOYED. IT WAS REPORTED THAT THE ROTATOR CUFF WAS TORN AGAIN; AND THAT THE SURGEON COMMENTED THAT THERE WAS A POSSIBILITY OF A FOREIGN BODY REACTION, AND SUSPICION OF INFECTION COULD NOT BE DENIED. IT WAS REPORTED THAT ALTHOUGH THERE WAS SOME PAIN, THE LIFT WAS STILL 130 TO 140 DEGREES ONE YEAR AFTER SURGERY COMPARED TO 80 TO 90 DEGREES BEFORE SURGERY. IT WAS REPORTED THAT THE SURGEON DID NOT THINK ABOUT INFECTION BECAUSE THE CRP WAS NOT HIGH; HOWEVER, INFECTION WAS SUSPECTED. THE SURGEON WILL FOLLOW UP THE PATIENT. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body Reaction; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17872707 ↗
• InjuryJan 30, 2023Break; Unintended Movement; Break; Unintended Movement

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRIA THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE INITIALLY PERFORMED ON (B)(6) 2022, THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2023 DUE TO CONTINUOUS PAIN FOR APPROXIMATELY THREE WEEKS AFTER THE INITIAL SURGERY IN THE SHOULDER JOINT. ACCORDING TO THE REPORT, DURING THE REVISION SURGERY, THE SURGEON RECOGNIZED THAT THE BRIDGE ON THE 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, WHITE/BLUE DEVICE WAS BROKEN FOR THE MEDIAL ROW ANCHOR. ADDITIONALLY, HE RECOGNIZED, THAT THE 5.5MM HEALIX ADVANCE KNOTLESS BR ANCHOR DEVICE FOR THE LATERAL ROW DID NOT TIGHTEN THE REPAIR - MEANING THAT THE TAPE GOT LOOSE BETWEEN THE OUTER ANCHOR BODY AND THE BONE. IT WAS REPORTED THAT BOTH ANCHORS WERE REMOVED AND ANOTHER LIKE DEVICES WERE IMPLANTED INTO THE NEW BONE HOLES. IT WAS REPORTED THAT NO PROBLEM WAS RECOGNIZED DURING THE INITIAL SURGERY AS THE MEDIA SHOWED A SOLID CONSTRUCT DURING THE PRIMARY SURGERY WHERE THE KNOTS ON THE MEDIAL SIDE WERE SOLID FIXED AS WELL AS THE LATERAL FIXATION. IT WAS REPORTED THAT DUE TO THE ONGOING PAIN OF THE PATIENT AND AN MR SCAN, THE SURGEON DECIDED TO HAVE A SE

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16264765 ↗
• MalfunctionJan 19, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP AND THREADED PART ON THE ANCHOR ON THE 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, WHITE/BLUE DEVICE GOT STRIPPED AND THEN BROKE UPON INSERTION. ACCORDING TO THE REPORT, THE EVENT OCCURRED AFTER THE SURGEON MADE A BURR HOLE BY AN AWL AND A TAP AND INSERTED THE ANCHOR BUT THE ANCHOR WAS DIFFICULT TO BE INSERTED. IT WAS REPORTED THAT THE SURGEON MADE ANOTHER BURR HOLE AT THE DIFFERENT PLACE FROM THE FIRST BURR HOLE AND INSERTED ANOTHER NEW ANCHOR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16210251 ↗
• MalfunctionNov 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A MINI OPEN ROTATOR CUFF REPAIR FOR TREATING SUPRASPINATUS AND INFRASPINATUS TEARS ON (B)(6) 2021, IT WAS OBSERVED THAT THE DEPLOYMENT OF THE 6.5 HEALIX ADVANCE KNTLS BR DEVICE WAS NOT COMPLETED. THE PROCEDURE WAS DELAYED FOR 60 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865210 ↗
• MalfunctionNov 24, 2020Break; Break

  T WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE IMPLANT BROKE UPON INSERTION DUE TO THE HARD BONE. A SECOND IMPLANT WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10897639 ↗
• MalfunctionOct 9, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR REVISION PROCEDURE THE CUSTOMER'S 5.5MM HEALIX ADVANCE ANCHOR WITH PERMATAPE, WHITE/BLUE BROKE JUST ABOVE THE THIRD THREAD ON THE DISTAL END. THE ANCHOR BROKE WHILE INSERTING AND THE PIECES ARE CONNECTED TOGETHER BY THE SUTURE. THE SALES REP STATED THAT THE PATIENT HAD A NORMAL BONE DENSITY AND THE SURGEON WAS INSERTING ON AXIS. THE ANCHOR WAS REMOVED FROM THE PATIENT WITH NO DEBRIS LEFT BEHIND. THE CASE WAS COMPLETED USING THE SAME BONE HOLE WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAY. THE ANCHOR IS BEING RETURNED FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 7948317 ↗
• MalfunctionSep 21, 2018Break; 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 ANCHOR WITH PERMATAPE BLUE BROKE INTO TWO PIECES WHEN IT WAS BEING INSERTED WITHOUT A TRIAL. THEY THEN USED THE SALES REP'S 5.5 HEALIX ADVANCE ANCHOR WITH PERMATAPE WHITE/BLUE, WHICH ALSO BROKE INTO TWO PIECES UPON INSERTION WITH A TRIAL. THE CASE WAS COMPLETED BY USING THE PERMATAPE FROM THE SECOND ANCHOR WITH NO PATIENT HARM, BUT THERE WAS A FIVE MINUTE DELAY TO OPEN ANOTHER ANCHOR. THE SALES REP STATED THEY DID NOT NEED TO CREATE ANOTHER BONE HOLE, THERE WERE NO DEBRIS LEFT IN THE PATIENT, OR ANY ABNORMAL PROCEDURAL OR ANATOMICAL FACTORS. THE DEVICES ARE BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7899042 ↗