ORTHOCORD HEALIX BR 222238Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705007844), received between Mar 22, 2018 and Oct 8, 2018 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY (B)(6) THAT DURING A SHOULDER ARTHROSCOPY, IT WAS OBSERVED THAT THE THREAD BROKE WHILE TIGHTENING THE KNOT ONCE THE ANCHOR WAS FIXED. ACCORDING TO THE REPORTER, THE ANCHOR WAS ALREADY SECURED WHEN THE THREAD BROKE. IT WAS REPORTED THAT THE ANCHOR STAYED INSIDE THE PATIENT AND WAS FIXED PROPERLY. THE SURGEON DID NOT HAVE TO USE AN ADDITIONAL ANCHOR DUE TO THIS FAILURE; HOWEVER, THERE WAS A DELAY OF 10 MIN TO COMPLETE THE PROCEDURE. THE SURGEON DID NOT HAVE TO MAKE AN ADDITIONAL BONE HOLE TO COMPLETE THIS PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 7943037 ↗
• MalfunctionSep 3, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING ROTATOR CUFF REPAIR, IT WAS OBSERVED THAT THE TIP OF THE CUSTOMER'S HEALIX BR 6.5MM ANCHOR WITH ORTHOCORD BROKE UPON INSERTION. THE SURGEON REMOVED THIS ANCHOR AND INSERTED ANOTHER SAME SIZE, SAME TYPE ANCHOR IN THE SAME BONEHOLE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR DELAY REPORTED. THE SALES REP WAS NOT PRESENT AND HAD NO FURTHER INFORMATION. THE CUSTOMER ALREADY DISCARDED THE COMPLAINT DEVICE. 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 7840608 ↗
• MalfunctionJul 27, 2018Break; Break

  IT WAS REPORTED THAT ANCHOR WAS BROKEN, DURING SCREWING. THE HOLE WAS PREPARED CORRECTLY WITH AWL AND THREAT THE TAP. WITH SAME LIKE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7726386 ↗
• MalfunctionJul 27, 2018Break; Break

  IT WAS REPORTED THAT ANCHOR WAS BROKEN, DURING SCREWING. THE HOLE WAS PREPARED CORRECTLY WITH AWL AND THREAT HET TAP. WITH SAME LIKE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7726384 ↗
• MalfunctionMay 8, 2018Break; Break

  THE AFFILIATE REPORTED VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE ONCE THE ANCHORS FIXED, THE THREAD BROKE. PER ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE ON 10-26-12017: THE PROCEDURE WAS A SHOULDER ARTHROSCOPY. THE ISSUE WAS DETECTED DURING USE. THERE WAS A 10 MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED. THE SUTURE BROKE WHEN TIGHTENING THE KNOT. THE SUTURE WAS NOT IN CONTACT WITH AN INSTRUMENT DURING BREAKAGE. A SUTURE CUTTER WAS NOT USED. PER ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE ON 11-17-2017: THE PROCEDURE WAS COMPLETED WITH THE ANCHOR. THE ANCHOR WAS NOT REMOVED. THE ORIGINAL BONE HOLE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7494866 ↗
• MalfunctionMay 8, 2018Break; Break

  THE AFFILIATE REPORTED VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE ONCE THE ANCHORS FIXED, THE THREAD BROKE. PER ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE ON 10-26-2017: THE PROCEDURE WAS A SHOULDER ARTHROSCOPY. THE ISSUE WAS DETECTED DURING USE. THERE WAS A 10 MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED. THE SUTURE BROKE WHEN TIGHTENING THE KNOT. THE SUTURE WAS NOT IN CONTACT WITH AN INSTRUMENT DURING BREAKAGE. A SUTURE CUTTER WAS NOT USED. PER ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE ON 11-17-2017: THE PROCEDURE WAS COMPLETED WITH THE ANCHOR. THE ANCHOR WAS NOT REMOVED. THE ORIGINAL BONE HOLE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7494809 ↗
• MalfunctionMar 22, 2018Break; Break

  THE AFFILIATE REPORTED VIA EMAIL THAT DURING A SHOULDER ARTHROSCOPY, ONCE THE ANCHOR FIXED, THE THREAD BROKE WHEN TIGHTENING THE KNOT. THE ANCHOR STAYED INPATIENT AND WAS FIXED PROPERLY. LOSS OF 10 MIN. NO PATIENT CONSEQUENCES. THE FOLLOWING ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON (B)(6) 2017 THE PROCEDURE WAS ABLE TO BE COMPLETED THE PROCEDURE WAS COMPLETED WITH THE ANCHOR THE ANCHOR WAS ALREADY SECURED WHEN THE THREAD BROKE THE SURGEON DID NOT HAVE TO USE AN ADDITIONAL ANCHOR DUE TO THIS FAILURE THE SURGEON DID NOT HAVE TO MAKE AN ADDITIONAL BONE HOLE TO COMPLETE THIS PROCEDURE IT IS UNKNOWN IF ALTERNATIVES WERE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7364166 ↗

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-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-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-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-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