HEALIX ADVANCE BR ANCHOR w/PERMATAPE PERMACORDRecalls & reported problems across all models

We found 4 models of HEALIX ADVANCE BR ANCHOR w/PERMATAPE PERMACORD by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between May 1, 2018 and Sep 25, 2026 — classified as 6 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Break” (36 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported HEALIX ADVANCE BR ANCHOR w/PERMATAPE PERMACORD problems

HEALIX ADVANCE BR ANCHOR w/PERMATAPE PERMACORD models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HEALIX ADVANCE BR ANCHOR w/PERMATAPE PERMACORD 222359

  Fastener, fixation, biodegradable, soft tissue
  26 reports
• HEALIX ADVANCE BR ANCHOR w/PERMATAPE PERMACORD 222360

  Fastener, fixation, biodegradable, soft tissue
  20 reports
• HEALIX ADVANCE BR ANCHOR w/PERMATAPE PERMACORD 222361

  Fastener, fixation, biodegradable, soft tissue
  13 reports
• HEALIX ADVANCE BR ANCHOR w/PERMATAPE PERMACORD 222362

  Fastener, fixation, biodegradable, soft tissue
  8 reports

Recent HEALIX ADVANCE BR ANCHOR w/PERMATAPE PERMACORD adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902591 ↗
• MalfunctionJun 15, 2026Break

  IT WAS REPORTED THE EVENT OCCURRED DURING A TRICEPS BRACHII TENDON REPAIR FOR TRICEPS RUPTURE. WHILE THE ANCHOR WAS INSERTED, IT WAS FOUND THAT THE TIP OF THE SCREW BROKE SLIGHTLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505586 ↗
• 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 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT DURING ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, THE HEALIX AV BR 4.5 TAPE BLUE DEVICE BROKE WHEN THE SURGEON TRIED TO INSERT IT INTO THE BONE TUNNEL AS INSTRUCTED IN THE PROCEDURE MANUAL. NO REMAINS WERE FOUND INSIDE THE BODY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER PRODUCT OF THE SAME TYPE. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369714 ↗
• MalfunctionDec 4, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, AFTER CREATING A BONE FORAMEN WITH AN AWL, THE SURGEON ATTEMPTED TO INSERT A HEALIX AV BR 4.5 TAPE WHT/BLUE, BUT THE ANCHOR WOULD NOT ADVANCE AND THE DEVICE BROKE. THE FRAGMENTS WERE RETRIEVED. ANOTHER SAME PRODUCT WAS USED WITHOUT ANY PROBLEMS. THE SURGEON ATTEMPTED TO THREAD THE SPECIFIED NUMBER OF SUTURES THROUGH THE 4.9MM HEALX ADV SP BIOC ANCHOR BUT FELT STRONG RESISTANCE. AFTER SOMEHOW MANAGING TO INSERT THE THREAD INTO THE ANCHOR, THE SURGEON OPERATED IT AS USUAL WHEN HE FOUND THAT THE ANCHOR HAD CRACKED, SO IT WOULD NOT BE USED. ANOTHER PRODUCT WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720493 ↗
• 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 ↗
• MalfunctionOct 31, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN OPEN ROTATOR CUFF REPAIR (ORCR) SURGICAL PROCEDURE, THE HEALIX AV BR 4.5 TAPE WHT/BLUE ANCHOR DEVICE WAS INSERTED ACCORDING TO PROCEDURE, HOWEVER, THE DEVICE DID NOT STAY IN PLACE AND CAME OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A 5.5MM ANCHOR DEVICE. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THE PATIENT, AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437570 ↗
• MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, IT WAS OBSERVED THAT THE HEALIX AV BR 4.5 TAPE BLUE DEVICE ANCHOR FELL OUT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23049041 ↗
• MalfunctionSep 11, 2025Migration; Migration

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT AFTER THE SURGEON INSERTED THE HEALIX AV BR 4.5 TAPE BLUE DEVICE ANCHOR AND MANIPULATED THE SUTURE, THE ANCHOR CAME OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031409 ↗
• MalfunctionJul 25, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT AFTER CREATING A BURR HOLE WITH AN AWL, THE SURGEON INSERTED AND TURNED THE ANCHOR ON THE HEALIX AV BR 4.5 TAPE WHT/BLUE DEVICE INTO THE BURR HOLE. DURING THIS PROCESS, THE TIP OF THE ANCHOR CRACKED, RESEMBLING A PEELING ACTION. THE SURGEON THEN USED ANOTHER DEVICE, WHICH OPERATED WITHOUT ANY ISSUES. BECAUSE OF THIS, THE EVENT WAS IDENTIFIED AS A POTENTIAL VULNERABILITY OF THE ORIGINAL DEVICE. THE BROKEN FRAGMENTS OF THE ANCHOR WERE SAFELY REMOVED FROM THE BODY, LEAVING NO FRAGMENTS BEHIND. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609146 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS FOUND THAT THE ANCHOR ON THE HEALIX AV BR 4.5 TAPE WHT/BLUE DEVICE WAS INSERTED FOLLOWING THE STANDARD PROCEDURE, BUT THE AWL BROKE DURING TAPPING. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327053 ↗
• MalfunctionJun 16, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE HEALIX AV BR 4.5 TAPE BLUE DEVICE WAS BEING USED WHEN THE PRODUCT WAS INSERTED INTO THE BONE HOLE AFTER USING DEDICATED INSTRUMENTS IN ACCORDANCE WITH THE ATTACHED INSTRUCTIONS. ALTHOUGH THE QUALITY OF THE BONE MAY HAVE BEEN AN INFLUENCE, THE PRODUCT BROKE WHILE INSERTING THE ANCHOR AND IT WAS NOT POSSIBLE TO INSERT IT INTO THE BONE. THE BROKEN ANCHOR WAS IN A BROKEN STATE AND WAS REMOVED IN ITS ENTIRETY FROM THE BODY. THE SURGERY WAS COMPLETED USING A DIFFERENT PRODUCT. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210267 ↗
• MalfunctionJun 9, 2025Break; Break

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, THE GRYPHON P BR DS ANCHOR W/OC DEVICE CAME OUT ON THE GLENOID SIDE AND THE HELIX DEVICE BROKE ON THE HUMERUS SIDE. THEY WERE REMOVED FROM THE PATIENT'S BODY AND THE SURGEON CONFIRMED THAT NO TRACES REMAINED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170120 ↗
• MalfunctionMay 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE HEALIX AV BR 4.5 TAPE WHT/BLUE DEVICE TIP BROKE. ALTHOUGH THE PATIENT HAD HARD BONE, THE TAP HAD BEEN CUT BEFORE USE AND THE SURGERY WAS CARRIED OUT ACCORDING TO THE RECOMMENDED PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY OR HARM TO THE PATIENT REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949228 ↗

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