HEALIX TRANSTEND ORTHOCORD 222265Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705008117), received between Jun 27, 2018 and Jun 20, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

5 other recalls cover devices cleared under the same FDA submission (K102298, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2024Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING A HIP SURGERY SURGICAL PROCEDURE ON (B)(6) 2024 THE HEALIX TRANSTEND BR ANC W/OC DEVICE TIP WAS CRACKED. ANOTHER IMPLANT WAS USED TO FINISH THE PROCEDURE. THE SURGEON OPTED TO USE A GRYPHON BASED ON THE BONE QUALITY AND FINISHED THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19578939 ↗
• MalfunctionJan 26, 2022Break; Break

  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 4.5 HEALIX BR ANCHOR W/OCORD ANCHOR DEVICE BROKE. ALL THE BROKEN PARTS WERE REMOVED. 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 13359971 ↗
• InjuryFeb 15, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA THE CST TOOL THAT DURING AN UNKNOWN PROCEDURE THE HEALIX ANCHOR 3.4 AND HEALIX ADVANCE KNOTLESS 4.75 BROKE WHEN INSERTED INTO BONE. THE PROCEDURE WAS COMPLETED WITH A THIRD DEVICE WITH A 10 MINUTE DELAY TO THE PROCEDURE. PART OF THE ANCHOR REMAINS IN THE PATIENT AS IT IS MADE OF BR MATERIAL AND THE SURGEON INSERTED THE NEW ANCHOR ON TOP OF THE BROKEN ONE. THE AFFILIATE DID NOT REPORT ANY PATIENT HARM. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE ON 02/14/19 REPORTING THERE WAS NO PLANNED SURGICAL INTERVENTION OR PATIENT HARM. THE AFFILIATE REPORTED THAT THE PATIENT HAD HARD BONE AND A DIFFERENT BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. THE SURGEON WAS NOT OFF AXIS AND ALL DEBRIS WAS REMOVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 8345451 ↗
• MalfunctionAug 24, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN THE (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE HEALIX PTRC BR ANCHOR DEVICE BROKE WHILE INSERTING THE HEALIX TRANSTEND ANCHOR (AFTER USING THE HEALIX TRANSTEND AWL/TAP. IT WAS REPORTED THAT THE SURGEON USED THE SAME CORNER AS THE AWL/TAP AND NO ABNORMAL RESISTANCE WAS PRESENT. IT WAS REPORTED THAT IT BROKE WITHOUT PRACTICAL/CLINICAL REASON. IT WAS REPORTED THAT BECAUSE THE ANCHOR WAS RIGID IN THE BONE, THE SURGEON CONTINUED THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR 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 7813695 ↗
• MalfunctionJun 27, 2018Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING PARTIAL FITNESS ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT TWO ANCHORS BROKE. ACCORDING TO THE REPORT, THE FIRST ANCHOR BROKE AT THE CORTICAL THREAD WHEN INSERTED AND HALF OF THE PIECE REMAINED IN SITU. IT WAS FURTHER REPORTED THAT THE SECOND ANCHOR BROKE WHEN FIRST ENTERED IN THE TAPPED HOLE AND BROKE IN HALF. IT WAS REPORTED THAT ANCHOR WAS REMOVED FROM THE PATIENT. THERE WAS TEN MINUTE DELAY IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A NEW ANCHOR WAS USED TO COMPLETE THE CASE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE 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 Consequences Or Impact To Patient

  MAUDE report 7641810 ↗
• MalfunctionJun 27, 2018Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING PARTIAL FITNESS ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT TWO ANCHORS BROKE. ACCORDING TO THE REPORT, THE FIRST ANCHOR BROKE AT THE CORTICAL THREAD WHEN INSERTED AND HALF OF THE PIECE REMAINED IN SITU. IT WAS FURTHER REPORTED THAT THE SECOND ANCHOR BROKE WHEN FIRST ENTERED IN THE TAPPED HOLE AND BROKE IN HALF. IT WAS REPORTED THAT ANCHOR WAS REMOVED FROM THE PATIENT. THERE WAS TEN MINUTE DELAY IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A NEW ANCHOR WAS USED TO COMPLETE THE CASE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE 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 Consequences Or Impact To Patient

  MAUDE report 7641805 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102298, K150209. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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