HEALIX ADVANCE PEEK ANCHOR w/PERMATAPE PERMACORD 222363Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705027835), received between Dec 28, 2020 and Oct 31, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, THE SURGEON PLACED THE HEALIX AV PK 4.5 TAPE BLUE ANCHOR DEVICE INTO THE BONE TO GO PAST THE FIRST SUTURE, UPON INSTANTLY HE NOTICED THAT THE SUTURE WAS NOT LOADED DIRECTLY INTO THE ANCHOR ITSELF, AND IT WAS TECHNICALLY UNLOADED FROM THE ANCHOR PRIOR TO PLACEMENT. IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437803 ↗
• MalfunctionSep 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TAPE CAME OUT OF THE 4.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH PERMATAPE¿ SUTURE, BLUE DEVICE WHEN THE SURGEON PLACED AND WANTED TO CYCLE THE TAPE SUTURE. THE SAME 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 15382685 ↗
• MalfunctionOct 21, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP OF THE ANCHOR ON THE HEALIX AV PK 4.5 TAPE BLUE DEVICE CRACKED WHEN IMPLANTING. ALL FRAGMENTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF TWO MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12673718 ↗
• InjuryFeb 11, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE AFFILIATE IN SWITZERLAND THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON 1/27/2021, IT WAS OBSERVED THAT THE HEALIX AV PK 4.5 TAPE BLUE DEVICE WAS TORN AS IT WAS THREADED THROUGH THE BONE. THE ANCHOR WAS LEFT INSIDE THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A 30 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11315803 ↗
• InjuryDec 28, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT A HEALIX AV PK 4.5 TAPE BLUE DEVICE BROKE DURING INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077565 ↗