HEALIX KNOTLESS BR 222286Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886705020386), received between Jun 20, 2018 and Sep 16, 2019 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP REPORTED THAT THE HEALIX KNOTLESS ANCHOR 4.75 MM DEVICE BROKE WHILE BEING INSERTED INTO THE BONE HOLE DURING A ROTATOR CUFF PROCEDURE. ACCORDING TO THE REPORT, THE SURGEON WAS ABLE TO COMPLETELY REMOVE THE ANCHOR. IT WAS FURTHER REPORTED THAT THE SURGEON INSERTED ANOTHER HEALIX ANCHOR INTO THE BONE HOLE BUT HAD TO REMOVE THE INSERTER TO FIND THE ORIGINAL BONE HOLE AND AS HE DID THIS THE SECOND ANCHOR FELL OFF THE INSERTER ONTO THE FLOOR. THE SURGEON THEN USED A COMPETITOR'S DEVICE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES BUT WITH A 10 MINUTE DELAY. THE SALES REP VERIFIED THAT THE BONE QUALITY WAS AVERAGE. THE SURGEON USED THE YELLOW HANDLED HEALIX AWL. SALES REP ALSO CONFIRMED THE SURGEON WAS NOT OFF AXIS AND THERE WAS NO AUDIBLE SOUND THAT THE ANCHOR BROKE. THE DEVICES WERE DISCARDED. THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL

  Patient problems: Not Applicable

  MAUDE report 9069776 ↗
• MalfunctionJul 17, 2018Device Damaged by Another Device; Device Damaged by Another Device

  AFFILIATE REPORTED THAT FIRST ANKER DAMAGED SUTTERS FROM THE FIRST ROW (ORTHOCORD); SECOND ANKER DIDN'T HOLD IN THE BONE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-52065.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7693543 ↗
• MalfunctionJul 17, 2018Device Damaged by Another Device; Device Damaged by Another Device

  AFFILIATE REPORTED THAT FIRST ANKER DAMAGED SUTERS FROM THE FIRST ROW (ORTHOCORD); SECOND ANKER DIDN'T HOLD IN THE BONE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-52070.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7693537 ↗
• MalfunctionJun 26, 2018Break; Break

  IT WAS INITIALLY REPORTED ONE ANCHOR BROKE AND ONE CAME OUT. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITH A LIKE DEVICE. ADDITIONAL COMPLAINT EVENT INFORMATION WAS RECEIVED FROM OUR AFFILIATE ON (B)(6) 2013. THE PATIENT HAD NORMAL BONE QUALITY, A HEALIX AWL WAS USED IN THE PROCEDURE, AND TWO (2) ARTHREX FIBER WIRE SUTURES WERE BEING USED WITH EACH ANCHOR. THERE WAS NO AUDIBLE OR TACTILE INDICATION OF FAILURE WITH EITHER ANCHOR. THE SURGEON WAS NOT USING THE PRODUCT FOR THE FIRST TIME. FOR THE ANCHOR WHICH PULLED OUT DURING THE PROCEDURE, IT PULLED OUT DURING VERIFICATION OF THE REPAIR STRENGTH. IT IS UNKNOWN WHAT TYPE OF FORCE WAS APPLIED, AND UNKNOWN IF THE TENDON SIDE OR FREE ENDS OF SUTURE WERE TESTED TO VERIFY THE REPAIR WHEN THE ANCHOR PULLED OUT. FOR THE ANCHOR WHICH BROKE DURING THE PROCEDURE, THE ANCHOR WAS NOT INSERTED OFF-AXIS AND NOT USED AS A LEVER. THE ANCHOR BROKE WHILE PULLING SUTURE THROUGH THE SYSTEM. IT IS UNKNOWN HOW LONG THE SUTURE LIMBS WERE, IF THEY WERE OF EQUAL LENGTH, OR IF THEY HAD BECOME TANGLED. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50868.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638719 ↗
• MalfunctionJun 26, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS INITIALLY REPORTED ONE ANCHOR BROKE AND ONE CAME OUT. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITH A LIKE DEVICE. ADDITIONAL COMPLAINT EVENT INFORMATION WAS RECEIVED FROM OUR AFFILIATE ON MAY 15, 2013. THE PATIENT HAD NORMAL BONE QUALITY, A HEALIX AWL WAS USED IN THE PROCEDURE, AND TWO (2) ARTHREX FIBER WIRE SUTURES WERE BEING USED WITH EACH ANCHOR. THERE WAS NO AUDIBLE OR TACTILE INDICATION OF FAILURE WITH EITHER ANCHOR. THE SURGEON WAS NOT USING THE PRODUCT FOR THE FIRST TIME. FOR THE ANCHOR WHICH PULLED OUT DURING THE PROCEDURE, IT PULLED OUT DURING VERIFICATION OF THE REPAIR STRENGTH. IT IS UNKNOWN WHAT TYPE OF FORCE WAS APPLIED, AND UNKNOWN IF THE TENDON SIDE OR FREE ENDS OF SUTURE WERE TESTED TO VERIFY THE REPAIR WHEN THE ANCHOR PULLED OUT. FOR THE ANCHOR WHICH BROKE DURING THE PROCEDURE, THE ANCHOR WAS NOT INSERTED OFF-AXIS AND NOT USED AS A LEVER. THE ANCHOR BROKE WHILE PULLING SUTURE THROUGH THE SYSTEM. IT IS UNKNOWN HOW LONG THE SUTURE LIMBS WERE, IF THEY WERE OF EQUAL LENGTH, OR IF THEY HAD BECOME TANGLED. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50870.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638700 ↗
• MalfunctionJun 22, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED BY OUR AFFILIATE THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, IT WAS OBSERVED THAT TWO HEALIX ANCHORS FAILED TO SECURE IN THE BONE HOLE. ACCORDING TO THE REPORT, THE DEVICES PULLED OUT WITH THE INSERTERS WHEN THE SURGEON HAD COMPLETED THE DEPLOYMENT. IT WAS REPORTED THAT THE ANCHOR PULLS OUT OCCURRED WHEN THE SURGEON HAD ALREADY PERFORMED A DOUBLE ROW FIXATION AND WAS FINISHING UP A THIRD ROW. IT WAS REPORTED THAT THE SURGEON DID NOT WANT TO BREACH THE BONE AGAIN, SO HE CONCLUDED THE FIXATION WITH A ¿POLYESTER-PATCH¿. IT WAS REPORTED THAT THE SURGEON WAS SATISFIED WITH THE REPAIR AND FINISHED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. PLEASE SEE ALSO MEDWATCH REPORT MWR-24052018-0000116569.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7629829 ↗
• MalfunctionJun 22, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED BY AFFILIATE THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, TWO HEALIX ANCHORS FAILED TO SECURE IN THE BONE HOLE; THEY PULLED OUT WITH THE INSERTERS WHEN THE SURGEON HAD COMPLETED THE DEPLOYMENT. THE SURGEON HAD ALREADY PERFORMED A DOUBLE ROW FIXATION AND WAS FINISHING UP A THIRD ROW WHEN THE ANCHOR PULL OUTS OCCURRED. THE SURGEON DID NOT WANT TO BREACH THE BONE AGAIN, SO HE CONCLUDED THE FIXATION WITH A ¿POLYESTER-PATCH¿. THE SURGEON WAS SATISFIED WITH THE REPAIR AND FINISHED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. PLEASE SEE ALSO MEDWATCH REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7629729 ↗
• MalfunctionJun 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE SALES REP REPORTED DURING A SHOULDER PROCEDURE THE ANCHOR PULLED OUT W/THE INSERTER. WE USED A 5.5 HEALIX ADVANCED ANCHOR AND HAD TO PASS THE SUTURE AGAIN. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFO FROM THE ADMINISTRATOR STATED THE DEVICE WAS DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7628964 ↗
• MalfunctionJun 21, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  THE SALES REP REPORTED TWO OF HIS 4.75MM HEALIX BR KNOTLESS ANCHOR'S PULLED OUT DURING A ROTATOR CUFF PROCEDURE. HE STATED THE SURGEON INSERTED THE FIRST ANCHOR AND IT STARTED TO PULL OUT WHILE REMOVING THE INSERTER. WHEN THE SURGEON WENT TO TEST THE STRENGTH OF THE SUTURES, THE ANCHOR PULLED OUT COMPLETELY. THE SURGEON MADE A NEW BONE HOLE AND INSERTED A SECOND ANCHOR. THE SECOND ANCHOR PULLED OUT WHILE THE SURGEON WAS TESTING THE STRENGTH OF THE SUTURES AS WELL. THE SURGEON USED THE APPROPRIATE FORCE WHEN INSERTING THE ANCHORS, EACH ANCHOR HAD 4 SUTURES AND HE WAS USING A SOFT BONE AWL. THE SURGEON MADE A THIRD BONE HOLE AND WAS ABLE TO SUCCESSFULLY INSERT A THIRD ANCHOR WITH NO ISSUES. THE PROCEDURE WAS DELAYED 20 MINUTES AND THERE WERE NO PATIENT CONSEQUENCES. BOTH ANCHORS WERE DISCARDED. THE SALES REP STATED THE PATIENT WAS AN (B)(6) MAN WITH VERY SOFT BONE AND BELIEVES THE ISSUES WERE PATIENT RELATED AND NOT IN RELATION TO THE DEVICE. NO FURTHER INFORMATION COULD BE PROVIDED. PLEASE SEE ALSO MEDWATCH REPORT: 1221934-2018-52194.

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

  MAUDE report 7626386 ↗
• MalfunctionJun 21, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  THE SALES REP REPORTED TWO OF HIS 4.75MM HEALIX BR KNOTLESS ANCHOR'S PULLED OUT DURING A ROTATOR CUFF PROCEDURE. HE STATED THE SURGEON INSERTED THE FIRST ANCHOR AND IT STARTED TO PULL OUT WHILE REMOVING THE INSERTER. WHEN THE SURGEON WENT TO TEST THE STRENGTH OF THE SUTURES, THE ANCHOR PULLED OUT COMPLETELY. THE SURGEON MADE A NEW BONE HOLE AND INSERTED A SECOND ANCHOR. THE SECOND ANCHOR PULLED OUT WHILE THE SURGEON WAS TESTING THE STRENGTH OF THE SUTURES AS WELL. THE SURGEON USED THE APPROPRIATE FORCE WHEN INSERTING THE ANCHORS, EACH ANCHOR HAD 4 SUTURES AND HE WAS USING A SOFT BONE AWL. THE SURGEON MADE A THIRD BONE HOLE AND WAS ABLE TO SUCCESSFULLY INSERT A THIRD ANCHOR WITH NO ISSUES. THE PROCEDURE WAS DELAYED 20 MINUTES AND THERE WERE NO PATIENT CONSEQUENCES. BOTH ANCHORS WERE DISCARDED. THE SALES REP STATED THE PATIENT WAS AN (B)(6) MAN WITH VERY SOFT BONE AND BELIEVES THE ISSUES WERE PATIENT RELATED AND NOT IN RELATION TO THE DEVICE. NO FURTHER INFORMATION COULD BE PROVIDED. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50752.

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

  MAUDE report 7626176 ↗
• MalfunctionJun 20, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THAT HER HEALIX KNOTLESS ANCHOR 4.75 MM BROKE WHILE BEING INSERTED INTO THE BONE HOLE DURING A ROTATOR CUFF PROCEDURE. THE SURGEON WAS ABLE TO COMPLETELY REMOVE THE ANCHOR. THE SURGEON INSERTED ANOTHER HEALIX ANCHOR INTO THE BONE HOLE BUT HAD TO REMOVE THE INSERTER TO FIND THE ORIGINAL BONE HOLE AND AS HE DID THIS THE SECOND ANCHOR FELL OFF THE INSERTER ONTO THE FLOOR. THE SURGEON THEN USED A COMPETITOR'S DEVICE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES BUT WITH A TEN (10) MINUTE DELAY. THE SALES REPRESENTATIVE VERIFIED THAT THE BONE QUALITY WAS AVERAGE. THE SURGEON USED THE YELLOW HANDLED HEALIX AWL. SHE ALSO CONFIRMED THE SURGEON WAS NOT OFF AXIS AND THERE WAS NO AUDIBLE SOUND THAT THE ANCHOR BROKE. THE DEVICES WERE DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7621817 ↗