HEALIX ADVANCE BR ANCHOR w/PERMATAPE PERMACORD 222361Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886705027811), received between May 1, 2018 and Apr 28, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, WHEN THE SURGEON ATTEMPTED TO PLACE THE HEALIX AV BR 5.5 TAPE BLUE ANCHOR DEVICE INTO THE FEMORAL HEAD, THE TIP OF THE IMPLANT BROKE. IT WAS REPORTED THAT ANOTHER SAME DEVICE WAS USED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017416 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE HEALIX AV BR 5.5 TAPE BLUE ANCHOR DEVICE DURING INSERTION, THE ANCHOR SPUN FREELY AND BROKE. ALL BROKEN ANCHORS WERE REMOVED FROM THE BODY. 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 24681795 ↗
• MalfunctionNov 14, 2025Use of Device Problem; Difficult to Advance; Material Deformation; Use of Device Problem; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHEN THE SURGEON USED THE HEALIX AV BR 5.5 TAPE BLUE ANCHOR DEVICE IT WAS OBSERVED THAT THE THREAD WAS DAMAGED AND THE ANCHOR COULD NOT BE INSERTED INTO THE BONE. THEREFORE, ANOTHER DEVICE WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO SURGICAL DELAYS AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556648 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 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, 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 17872701 ↗
• MalfunctionFeb 23, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, BLUE DEVICE BROKE DURING INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16431589 ↗
• MalfunctionJan 5, 2022Migration; Migration

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2021 TREATING A TEAR IN THE RIGHT SHOULDER, IT WAS OBSERVED THAT THE HEALIX AV BR 5.5 TAPE BLUE ANCHOR DEVICE WAS NOT DEPLOYED IN PLACE UPON INSERTION; AND CAME OFF THE BURR HOLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. WITH LESS THAN 30-MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY 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 13170644 ↗
• InjuryNov 23, 2021Migration; Migration

  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 ANCHOR ON THE HEALIX AV BR 5.5 TAPE BLUE DEVICE CAME OFF DURING REINSERTION; AND THAT THE BONE WAS GOUGED. 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: Unspecified Tissue Injury

  MAUDE report 12865265 ↗
• MalfunctionJun 30, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH PERMATAPE¿ SUTURE, BLUE DEVICE BROKE UPON INSERTION. 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 12094932 ↗
• MalfunctionMay 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TAPE CAME OFF ON THE HEALIX AV BR 5.5 TAPE BLUE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN HOUR DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11876471 ↗
• MalfunctionDec 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE SUTURE CAME OFF THE ANCHOR WHILE BEING RETRACTED FROM THE JOINT WITH A RETRIEVER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. 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 11089743 ↗
• MalfunctionOct 4, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE CUSTOMER'S 5.5 HEALIX ADVANCE ANCHOR WITH BLUE PERMATAPE SUTURE BROKE UPON INSERTION. THE ANCHOR WAS BROKEN MIDWAY DOWN. THE ANCHOR WAS REMOVED FROM THE PATIENT WITH NO FRAGMENTS LEFT BEHIND. THE SALES REP STATED THE PATIENT HAD NORMAL BONE DENSITY. THE CASE WAS COMPLETED USING ANOTHER LIKE-DEVICE IN THE SAME BONE HOLE WITH NO PATIENT HARM OR DELAYS. THE DEVICE 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 7934593 ↗
• 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 7899040 ↗
• MalfunctionMay 1, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THEIR HEALIX ADVANCE BR 5.5 TAPE BLUE ANCHOR BROKE AT THE TIP UPON INSERTION DURING A ROTATOR CUFF REPAIR. THE BROKE PARTS WERE REMOVED WITH A GRASPER AND ANOTHER LIKE DEVICE WAS PUT IN THE SAME BONE HOLE TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7476889 ↗