ORTHOCORD HEALIX BR 222232Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10886705007783), received between Jun 13, 2018 and Nov 13, 2020 — classified as 2 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (29 reports).

6 other recalls cover devices cleared under the same FDA submission (K073412, K150209); they may or may not involve this specific model.

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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ANCHOR DEVICE BROKE WHEN TRANSFERRED TO THE IMPLANT AND COULD NOT BE REMOVED. ANOTHER HOLE WAS PUNCHED TO IMPLANT ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Injury

  MAUDE report 10836791 ↗
• MalfunctionOct 8, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE THAT THE DOCTOR REAMED THE HOLE WITH 5.5AWL AND PUNCHED 5.5 HEALIXBR, BUT WHEN THE TRANSFERRED IMPLANT WAS ALMOST SUBMERGED, IT WOULD BE IDLING. THE TRANSFERRED IMPLANT WAS GOING TO BE LEFT WITH THE REST, AND THEN REMOVED THE SECOND 5.5 HEALIXBR FOR IMPLANTATION. THE PROCESS WENT SMOOTHLY.THE OTHER SIDE OF THE ELBOW IMPLANTED WITH 5.5 HEALIXBR IS STILL BROKEN, AND ANOTHER 5.5 HEALIXBR IS REMOVED, AND IT IS SUCCESSFULLY IMPLANTED. IT IS UNKNOWN IF A SURGICAL DELAY OR SURGICAL INTERVENTION OCCURRED. IT WAS ALSO REPORTED IT WAS UNKNOWN IF ALL BROKEN FRAGMENTS WERE REMOVED.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 10653201 ↗
• MalfunctionOct 8, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE THAT THE DOCTOR REAMED THE HOLE WITH 5.5AWL AND PUNCHED 5.5 HEALIXBR, BUT WHEN THE TRANSFERRED IMPLANT WAS ALMOST SUBMERGED, IT WOULD BE IDLING. THE TRANSFERRED IMPLANT WAS GOING TO BE LEFT WITH THE REST, AND THEN REMOVED THE SECOND 5.5 HEALIXBR FOR IMPLANTATION. THE PROCESS WENT SMOOTHLY.THE OTHER SIDE OF THE ELBOW IMPLANTED WITH 5.5 HEALIXBR IS STILL BROKEN, AND ANOTHER 5.5 HEALIXBR IS REMOVED, AND IT IS SUCCESSFULLY IMPLANTED. IT IS UNKNOWN IF A SURGICAL DELAY OR SURGICAL INTERVENTION OCCURRED. IT WAS ALSO REPORTED IT WAS UNKNOWN IF ALL BROKEN FRAGMENTS WERE REMOVED.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 10653175 ↗
• MalfunctionMar 25, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE THE 5.5 HEALIX BR ANCHOR W/OC&ND WAS BROKEN. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9879905 ↗
• MalfunctionJan 15, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED BY AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE 5.5 HEALIX BR ANCHOR W/OC&ND WAS PULLING AT THE ANCHOR INSERTION. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593109 ↗
• InjuryNov 22, 2019Detachment 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, IT WAS OBSERVED THAT THE 5.5 HEALIX BR ANCHOR W/OC&ND DEVICE SNAPPED IN THE DENSE BONE WHEN IT WAS PLACED CORRECTLY IN THE FIBULA. AS PER THE AFFILIATE THE CORRECT SURGICAL TECHNIQUE WAS USED. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS ANODELAY 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 BE SUBMITTED ACCORDINGLY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9364544 ↗
• MalfunctionJun 24, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION RECEIVED FROM AFFILIATE REPORTING THE SUTURE BROKE DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR AND THE SUTURE WAS IN CONTACT WITH AN INSTRUMENT DURING BREAKAGE. IT WAS ALSO REPORTED AN ARTHREX¿S SUTURE PASSER WAS USED INSTEAD AND A SUTURE CUTTER WAS NOT UTILIZED. THE AFFILIATE ALSO REPORTED THE SURGEON UTILIZED PROPER SUTURE MANAGEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8728386 ↗
• MalfunctionJan 16, 2019Fracture; Fracture

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THE 5.5 HEALIX BR ANCHOR W/OC&ND DEVICE BROKE UPON INSERTION. ACCORDING TO THE REPORTER, THE SURGEON BLAMED HIMSELF FOR APPLYING TOO MUCH PRESSURE ON THE ANCHOR. THE ENTIRE ANCHOR WAS REMOVED AND ANOTHER ONE WAS OPENED AND WENT IN NICELY. THE PROCEDURE WAS DELAYED A MINUTE OR TWO DUE TO THE ANCHOR BREAKING. 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 8252683 ↗
• MalfunctionJan 14, 2019Material Frayed; Material Split, Cut or Torn; Program or Algorithm Execution Problem; Material Frayed; Material Split, Cut or Torn; Program or Algorithm Execution Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE THREAD ON THE 5.5 HEALIX BR ANCHOR W/OC&ND DEVICE WAS RIPPED DURING KNOTTING. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT WITH FIVE MINUTE DELAY. 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 8245006 ↗
• MalfunctionSep 4, 2018Break; Break

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE AT THE MOMENT OF PRODUCT¿S INTRODUCTION IN THE PATIENT, THE ANCHOR FROM ONE (1) 5.5 MM HEALIX BR ANCHOR WITH ORTHOCORD ANCHOR AND NEEDLE BROKE IN HALF ON ITS GUIDE. THE PRODUCT WAS REPLACED BY ANOTHER AS REQUESTED BY THE DOCTOR AND PROCEDURE WAS COMPLETED USING THE SAME LIKE PRODUCT. THE SURGEON SAID THAT THE PRODUCT BROKE DUE TO MANUFACTURING DEFECT. IT WAS ALSO REPORTED THAT THE PATIENT HAD HARD BONE. THERE WERE NO ADVERSE EVENTS WITH THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7843740 ↗
• MalfunctionSep 3, 2018Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE HEALIX BR ANCHOR, 5.5 MM - W/ORTHOCORD & NEEDLES DEVICE BROKE WHILE SCREWING IN. IT WAS REPORTEDLY NOT OFF-AXIS, BONE STRUCTURE NORMAL TO HARD. THERE WAS A DELAY OF 15 MINUTES. IT WAS REPORTED THAT THE DEVICE WAS ABLE TO BE REMOVED. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 7840917 ↗
• MalfunctionAug 30, 2018Break; Break

  DURING AN ANKLE PROCEDURE, THE HEALIX ANCHOR SNAPPED MIDWAY DURING INSERTION. NO EXCESS FORCE WAS APPLIED TO THE INSERTION AND PRE DRILL AND TAPPING OCCURRED. THE BOTTOM HALF OF THE ANCHOR GAVE SUFFICIENT HOLD TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7836154 ↗
• MalfunctionAug 21, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7802610 ↗
• MalfunctionAug 8, 2018Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A KNEE ARTHROSCOPY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THERE WAS RUPTURE ON THE TWO HEALIX BR ANCHOR, 5.5 MM - W/ORTHOCORD & NEEDLES DEVICES AND ITS THREAD. IT WAS REPORTED THAT NOTHING FELL INTO THE PATIENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 7763375 ↗
• MalfunctionAug 8, 2018Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A KNEE ARTHROSCOPY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THERE WAS RUPTURE ON THE TWO HEALIX BR ANCHOR, 5.5 MM - W/ORTHOCORD & NEEDLES DEVICES AND ITS THREAD. IT WAS REPORTED THAT NOTHING FELL INTO THE PATIENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 7763368 ↗
• MalfunctionAug 8, 2018Break; Break

  IT WAS REPORTED THE DEVICE BROKEN WHEN IT WAS BEING INTRODUCED INTO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7762454 ↗
• MalfunctionAug 2, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP OF LUPINE ANCHO BROKE IN THE PATIENT AT THE TIME OF INTRODUCTION. IT WAS REPORTED THAT IT REPLACED BY ANOTHER ANCHOR LUPINE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE. 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 7742710 ↗
• MalfunctionJul 24, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE THAT THE ANCHOR WAS BROKEN DURING DRAWING IT IN. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7716131 ↗
• MalfunctionJul 23, 2018Break; Break

  IT WAS REPORTED THAT A HEALIX BR ANCHOR HAD IT'S TIP BREAK OFF DURING INSERTION FOR A ROTATOR CUFF SURGERY. SURGEON COMPLETED SURGERY WITHOUT ISSUE. NO DELAY TO SURGERY OR AE TO PATIENT REPORTED. ADDITIONAL INFORMATION FROM AFFILIATE (B)(6) 2014. THE LOT NUMBER WAS VERIFIED AND CONFIRMED AS 3629664. ALL THE BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT BODY. THE BONE QUALITY OF THE PATIENT WAS HARD. THE CORRECT AWLS AND TAPS WERE USED IN THE PROCEDURE. THE INSERTION WAS NOT OFF-AXIS. THE SIZE OF THE ANCHOR USED TO COMPLETE THE PROCEDURE WAS 5.5MM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7711276 ↗
• MalfunctionJul 19, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR WAS BROKEN AT THE BEGINNING OF THE INSERTION. IT WAS REPORTED THAT THE SURGEON WAS NOT OFF AXIS AND THERE WERE TWO TAILS OF SUTURE USED. ACCORDING TO THE REPORTER, THE ANCHOR BROKE AT "THE SUTURE BRIDGE NEAR TO THE END OF THE THREAD", THE BONE QUALITY WAS NORMAL, AND THE BONE HOLE WAS PREPPED WITH THE AWL. THERE WAS A FIVE MINUTE DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 7704523 ↗
• MalfunctionJul 17, 2018Break; Break

  IT WAS REPORTED BY AFFILIATE THAT THE ANCHOR BROKE WHEN IT WAS BEING INTRODUCED INTO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7693795 ↗
• MalfunctionJul 16, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE THAT UPON KNOT TYING, ONE STRAND OF THE ORTHOCORD SUTURE FROM EACH ANCHOR BROKE. USE THE REMNANT TO COMPLETE THE KNOT TYING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7691241 ↗
• MalfunctionJul 16, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE THAT UPON KNOT TYING, ONE STRAND OF THE ORTHOCORD SUTURE FROM EACH ANCHOR BROKE. USE THE REMNANT TO COMPLETE THE KNOT TYING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7691216 ↗
• MalfunctionJul 16, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE KNEE, IT WAS OBSERVED THAT THE ABSORBABLE ANCHOR DEVICE BROKE DURING INSERTION INTO THE UPPER POLE OF THE PATELLA FOR THE REPAIR OF THE QUADRICEPS TENDON. ACCORDING TO THE REPORT, THE ANCHOR BROKE AND THE THREADS LOOSENED THE ANCHOR. IT WAS REPORTED THAT THE DEVICE WAS REPLACED AND THE PATIENT DID NOT HAVE ANY COMPLICATIONS. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. 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 7691133 ↗
• MalfunctionJul 6, 2018Break; Break

  AFFILIATE REPORTED BROKEN ANCHOR DURING SURGERY AND INSERT OF THE HEALIX BR. TWO WERE USED, ONE BROKE -- BUT THEY ARE NOT SURE WHICH ONE BROKE. THE RIGHT AWL WAS USED WITH THIS CASE. THE ANCHOR BROKE OBLIQUELY AT THE END TIP. THEY HAVE THROWN OUT THE BROKEN ANCHOR. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51327.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7667026 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073412, K150209. One submission often covers many models, so check the product and lot details in each record.

• Z-1677-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
• Z-1680-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
• Z-1681-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
• Z-1678-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
• Z-1679-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
• Z-2208-2011 · Feb 24, 2011 · Terminated
  DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD Product Code: 210811 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Bic