HEALIX KNOTLESS PEEK 222287Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705020393), received between Jun 13, 2018 and Mar 31, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• InjuryMar 31, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE ON THE 4.75 HEALIX ADVANCE KNTLSS BR DEVICE BROKE AND WAS LEFT WITHIN THE PATIENT. ANOTHER BONE HOLE WAS CREATED TO PASS ANOTHER ANCHOR TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF 30 MINUTES IN THE PROCEDURE. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 11594781 ↗
• MalfunctionJun 29, 2018Break; Break

  THE SALES REP REPORTED THAT HIS HEALIX PEEK KNOTLESS ANCHOR 4.75 CUT THE SUTURE AS IT WAS BEING IMPLANTED IN A SHOULDER PROCEDURE. THE SURGEON COMPLETELY REMOVED THE 1ST ANCHOR, AND IMPLANTED ANOTHER SAME LIKE ANCHOR INTO THE SAME BONE HOLE WITH THE SAME RESULT. THE SURGEON DECIDED HE HAD ENOUGH ANCHORS IN PLACE AND DISCARDED THE SECOND ANCHOR. THE SURGEON COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES AND NO TIME DELAY. BOTH ANCHORS WERE DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652630 ↗
• MalfunctionJun 29, 2018Break; Break

  THE SALES REP REPORTED THAT HIS HEALIX PEEK KNOTLESS ANCHOR 4.75 CUT THE SUTURE AS IT WAS BEING IMPLANTED IN A SHOULDER PROCEDURE. THE SURGEON COMPLETELY REMOVED THE 1ST ANCHOR, AND IMPLANTED ANOTHER SAME LIKE ANCHOR INTO THE SAME BONE HOLE WITH THE SAME RESULT. THE SURGEON DECIDED HE HAD ENOUGH ANCHORS IN PLACE AND DISCARDED THE SECOND ANCHOR. THE SURGEON COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES AND NO TIME DELAY. BOTH ANCHORS WERE DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652601 ↗
• MalfunctionJun 22, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT AFTER SURGEON INSERTED THE ANCHOR, ON REMOVAL OF INSERTER HANDLE THE ANCHOR PULLED OUT. THE SURGEON USED COMPETITOR ANCHOR TO COMPLETE THE REPAIR. THE COMPLAINT DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7630524 ↗
• MalfunctionJun 21, 2018Mechanical Jam; Mechanical Jam

  THE SALES REPRESENTATIVE REPORTED TWO DIFFERENT ISSUES WITH TWO OF THEIR HEALIX KNOTLESS ANCHOR'S DURING A ROTATOR CUFF PROCEDURE. SHE STATED THE FIRST ANCHOR WAS DIFFICULT TO LOAD AND THE SUTURES JAMMED THE INSERTER. THE SURGEON REMOVED THAT ANCHOR AND LOADED A SECOND ANCHOR ONTO THE INSERTER. THE SECOND ANCHOR PULLED OUT AFTER INSERTING IT INTO THE BONE HOLE. THE SURGEON HAD ENOUGH ANCHORS IN THE PATIENT SO HE DID NOT HAVE TO USE ANOTHER ANCHOR TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS NO DELAY AND THE CUSTOMER ALREADY DISCARDED THE COMPLAINT DEVICES. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50731.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7624368 ↗
• MalfunctionJun 21, 2018Unintended Movement; Unintended Movement

  THE SALES REPRESENTATIVE REPORTED TWO DIFFERENT ISSUES WITH TWO OF THEIR HEALIX KNOTLESS ANCHOR'S DURING A ROTATOR CUFF PROCEDURE. SHE STATED THE FIRST ANCHOR WAS DIFFICULT TO LOAD AND THE SUTURES JAMMED THE INSERTER. THE SURGEON REMOVED THAT ANCHOR AND LOADED A SECOND ANCHOR ONTO THE INSERTER. THE SECOND ANCHOR PULLED OUT AFTER INSERTING IT INTO THE BONE HOLE. THE SURGEON HAD ENOUGH ANCHORS IN THE PATIENT SO HE DID NOT HAVE TO USE ANOTHER ANCHOR TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS NO DELAY AND THE CUSTOMER ALREADY DISCARDED THE COMPLAINT DEVICES. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50725.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7624352 ↗
• MalfunctionJun 18, 2018Break; Break

  THE SALES REP REPORTED THAT DURING A ROTATOR CUFF PROCEDURE THE CUSTOMER'S HEALIX PEEK KNOTLESS ANCHOR 4.75MM BROKE WHILE BEING TAPPED INTO THE BONE HOLE. THE BONE QUALITY WAS AVERAGE AND THE SURGEON USED THE GREY HANDLE AWL. WHEN THE ANCHOR WAS FIRST INSERTED IT WAS SITTING PROUD IN THE BONE HOLE AND THE SURGEON TAPPED THE ANCHOR TO PUSH IT IN FURTHER WHEN IT BROKE . THERE WAS NO AUDIBLE SOUND. THE SURGEON COMPLETED REMOVED THE ANCHOR, MADE A NEW WIDER BONE HOLE AND INSERTED ANOTHER SAME LIKE ANCHOR WITH NO PATIENT CONSEQUENCES OR DELAY TO COMPLETE THE PROCEDURE. THE 1ST ANCHOR WAS DISCARDED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7610761 ↗
• MalfunctionJun 13, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED AN ARTHREX BIO-CORKSCREW ANCHOR AND HEALIX KNOTLESS WAS USED AS THE LATERAL ROW ANCHOR. ANCHOR DID NOT BITE TO THE BONE AND PULLED OUT OF THE BONE. THE ANCHOR DID NO DISENGAGE FROM THE INSERTER AND IS STUCK TO THE INSERTER. THE SUTURE HAD TO BE CUT FROM THE ANCHOR FOR THE SURGEON TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7597445 ↗