HEALIX PEEK ORTHOCORD 222209Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886705007578), received between Jul 5, 2018 and Apr 26, 2023 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (21 reports).

5 other recalls cover devices cleared under the same FDA submission (K071481, 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 5.5MM HEALIX PEEK ANCHOR W/ORTHOCORD DEVICE BROKE OFF. REMOVED ALL THE BROKEN PARTS AND ANOTHER LIKE 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 16818226 ↗
• MalfunctionMar 20, 2023Migration; Migration

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN INDIA THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 5.5MM HEALIX PEEK ANCHOR W/ORTHOCORD DEVICE CAME OUT. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 16574940 ↗
• MalfunctionOct 6, 2022Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE 5.5MM HEALIX PEEK ANCHOR W/ORTHOCORD DEVICE BROKE. ALL THE BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER ONE BUT THE SAME ISSUE HAPPENED AGAIN. ANOTHER LIKE 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 15553661 ↗
• MalfunctionOct 6, 2022Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4).IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE 5.5MM HEALIX PEEK ANCHOR W/ORTHOCORD DEVICE BROKE. ALL THE BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER ONE BUT THE SAME ISSUE HAPPENED AGAIN. ANOTHER LIKE 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 15553104 ↗
• MalfunctionMay 20, 2022Migration; Migration

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE 5.5 HEALIX PEEK ANCH.W/OCORD DEVICE PULLED OUT WHILE TIGHTENING THE SUTURE. ANOTHER LIKE 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 14455620 ↗
• MalfunctionDec 7, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE 5.5 HEALIX PEEK ANCH.W/OCORD DEVICE BROKE DURING INSERTION. ANOTHER LIKE 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 12954678 ↗
• MalfunctionNov 16, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE SURGEON WAS ABLE TO USE THE SAME BONE HOLE TO IMPLANT THE SECOND ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Not Applicable

  MAUDE report 10848140 ↗
• MalfunctionNov 16, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT TWO HEALIX ANCHORS BROKE AT THE TIP WHILE SURGEON WAS TRYING TO DEPLOY IT IN A ROTATOR CUFF SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT CONSEQUENCE. THERE WAS A DELAY OF 15 MINUTES. FRAGMENTS WERE GENERATED, REMOVED SUCCESSFULLY. THE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Not Applicable

  MAUDE report 10848121 ↗
• MalfunctionOct 12, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR THE TIP OF THE 5.5MM HEALIX PEEK ANCHOR W/ORTHOCORD BROKE UPON INSERTION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES, OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10662201 ↗
• MalfunctionJun 9, 2020Break; Break

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE, WHILE USING 5.5 MM HEALIX PEEK ANCHOR W/ ORTHOCORD, THE TIP BROKE OFF BEFORE INSERTING IMPLANT INTO THE HOLE, DOCTOR REACHED FOR ANOTHER IMPLANT AND IT BROKE AGAIN. A MITEK FASTIN ANCHOR WAS USED TO COMPLETE THE SURGERY WITH A DELAY OF 5 MINUTES. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Not Applicable

  MAUDE report 10135570 ↗
• MalfunctionJun 9, 2020Break; Break

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE, WHILE USING 5.5 MM HEALIX PEEK ANCHOR W/ORTHOCORD, THE TIP BROKE OFF BEFORE INSERTING IMPLANT INTO THE HOLE, DOCTOR REACHED FOR ANOTHER IMPLANT AND IT BROKE AGAIN. A MITEK FASTIN ANCHOR WAS USED TO COMPLETE THE SURGERY WITH A DELAY OF 5 MINUTES. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Not Applicable

  MAUDE report 10135503 ↗
• MalfunctionMay 8, 2020Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY OF MEDIAL COLLATERAL LIGAMENT REPAIR, WHEN INSERTING THE ANCHOR 4.5 HEALIX PEEK ANCH.W/OCORD, THE ANCHOR WAS BROKEN OFF. THIS ISSUE RE-OCCURRED ON 222209(5.5 HEALIX PEEK ANCH.W/OCORD). ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10040599 ↗
• MalfunctionMar 6, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE THE POINT OF THE 5.5 HEALIX PEEK ANCH.W/OCORD 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 9802375 ↗
• MalfunctionSep 25, 2019Break; Break

  HIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT GRYPHON BR ANCHOR WAS BENT ( IN NEW BOX) AND THEIR HEALIX PEEK ANCHOR WAS BROKEN ( IN THE BOX). IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF ANY 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 Known Impact Or Consequence To Patient

  MAUDE report 9119215 ↗
• MalfunctionAug 28, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE DISTAL TIP OF THE CUSTOMER'S 5.5MM HEALIX PEEK ANCHOR WITH ORTHOCORD BROKE UPON INSERTION. THE SALES REP STATED THAT THE SURGEON WAS OFF AXIS. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASEE. THE SALES REP STATED THAT NO DEBRIS WAS LEFT IN THE PATIENT. THE PATIENT'S BONE QUALITY WAS AVERAGE. THE DEVICE WILL BE RETURNING FOR EVALUATION. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8942652 ↗
• MalfunctionJan 17, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMER'S HEALIX 5.5MM PEEK ANCHOR WITH ORTHOCORD BROKE UPON INSERTION. THE SALES REP REPORTED THAT THE BROKEN ANCHOR WAS FULLY REMOVED. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE ANCHOR IN THE SAME BONE TUNNEL WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP REPORTED THAT THE ANCHOR BROKE DUE TO USER TECHNIQUE. 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 8257775 ↗
• MalfunctionOct 31, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED TWO SUTURES FOR TWO OF THE CUSTOMER'S HEALIX PEEK 5.5MM ANCHORS BROKE WHILE TRYING TO TIE SUTURES DURING A ROTATOR CUFF PROCEDURE. THE SALES REPRESENTATIVE STATED THE SURGEON WAS ABLE TO USE THE OTHER SUTURES TO TIE DOWN THE ANCHORS WITH NO PATIENT CONSEQUENCES OR DELAYS. THERE WAS NOTHING BROKEN LEFT INSIDE THE PATIENT. THE CUSTOMER REQUESTED REPLACEMENTS OF ALL THE ANCHORS LEFT ON HIS SHELF OF THIS LOT. THE SALES REPRESENTATIVE IS RETURNING ALL THE ANCHORS ON THE SHELF FOR EVALUATION. THE SALES REPRESENTATIVE STATED IT WAS GOOD BONE AND HAD NO PATIENT INFORMATION TO PROVIDE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50975.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8024361 ↗
• MalfunctionOct 31, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED TWO SUTURES FOR TWO OF THE CUSTOMER'S HEALIX PEEK 5.5MM ANCHORS BROKE WHILE TRYING TO TIE SUTURES DURING A ROTATOR CUFF PROCEDURE. THE SALES REPRESENTATIVE STATED THE SURGEON WAS ABLE TO USE THE OTHER SUTURES TO TIE DOWN THE ANCHORS WITH NO PATIENT CONSEQUENCES OR DELAYS. THERE WAS NOTHING BROKEN LEFT INSIDE THE PATIENT. THE CUSTOMER REQUESTED REPLACEMENTS OF ALL THE ANCHORS LEFT ON HIS SHELF OF THIS LOT. THE SALES REPRESENTATIVE IS RETURNING ALL THE ANCHORS ON THE SHELF FOR EVALUATION. THE SALES REPRESENTATIVE STATED IT WAS GOOD BONE AND HAD NO PATIENT INFORMATION TO PROVIDE. PLEASE SEE ALSO MEDWATCH REPORT: 1221934-2018-50974.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8024343 ↗
• MalfunctionAug 24, 2018Break; Break

  THE SALES REP REPORTED PHYSICIAN WAS USING 5.5 HEALIX FOR RTC PROCEDURE ON A (B)(6) PATIENT. INSERTED ANCHOR INTO BONE AFTER USING AWL AND ANCHOR SHEARED AT DISTAL TIP. PHYSICIAN THEN OPENED A SMALLER 4.5 HEALIX PEEK AND THAT ANCHOR SHEARED AT DISTAL TIP. PHYSICIAN THEN TAPPED AND USED A 3RD ANCHOR WHICH WENT IN VERY VERY TIGHT BUT DID NOT BREAK. REMOVED BOTH BROKEN ANCHORS, TAPPED AND USED A 3RD HEALIX PEEK. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7811966 ↗
• MalfunctionAug 14, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED VIA PHONE THAT THE CUSTOMER'S HEALIX 5.5MM PEEK WITH ORTHOCORD BROKE UPON INSERTION CRACKED AT THE FIRST THREAD AND WAS NOT GOING OUT. THE SALES REPRESENTATIVE STATED THAT THE PATIENT HAD HARD BONE. THE CASE WAS COMPLETED USING ANOTHER ANCHOR WITH THE SAME BONE HOLE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7781647 ↗
• MalfunctionJul 27, 2018Break; Break

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE HEALIX PEEK ANCHOR 5.5MM W/ ORTHOCORD TIP BROKE ON INSERTION. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH A LIKE DEVICE. THE SALES REPRESENTATIVE REPORTED THAT THERE WAS NO DELAY AND NO CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7727921 ↗
• MalfunctionJul 16, 2018Break; Break

  THE SALES REP REPORTED THE CUSTOMER'S HEALIX PEEK 5.5 MM ANCHOR BROKE UPON INSERTION AT THE DISTAL TIP DURING A ROTATOR CUFF PROCEDURE. THE SURGEON REMOVED ALL BROKEN FRAGMENTS OF THE DEVICE AND INSERTED ANOTHER ANCHOR TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. IT WAS AVERAGE BONE QUALITY AND THE COMPLAINT DEVICE WAS ALREADY DISCARDED BY THE CUSTOMER. THE SALES REP WAS NOT PRESENT AND COULD NOT PROVIDE FURTHER DETAILS ABOUT THE PROCEDURE OR ABOUT THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7689255 ↗
• MalfunctionJul 5, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE EYELET ON THE CUSTOMER'S 5.5MM HEALIX PEEK ANCHOR BROKE DURING INSERTION INTO THE BONE HOLE DURING A ROTATOR CUFF PROCEDURE. THE SURGEON REMOVED THE BROKEN ANCHOR AND ALL BROKEN PIECES AND INSERTED ANOTHER ANCHOR INTO THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE WAS ALREADY DISCARDED BY THE CUSTOMER. THE PATIENT HAD AVERAGE BONE QUALITY. THE SALES REP DID NOT HAVE ANY FURTHER INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7665185 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071481, K150209. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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