HEALIX TRANSTEND ORTHOCORD 222271Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886705008162), received between Jun 25, 2018 and Jan 24, 2022 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2022Migration; Migration

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF THE PRODUCT HEALIX TI WITH ORTHOCORD DEVICE THAT POSTOPERATIVELY TO AN ACHILLES TENDON REPAIR OF THE LEFT ANKLE PERFORMED ON (B)(6) 2019, IT WAS OBSERVED THAT THE PATIENT HAD POSTOPERATIVE ANCHOR MIGRATION, BREAKAGE OR LOOSENING ON (B)(6) 2019. ACCORDING TO THE REPORT, THE PATIENT HAD A REOPERATION ON (B)(6) 2019 DUE TO RE-TEAR OF ACHILLES TENDON. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13337940 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF THE PRODUCT HEALIX TI WITH ORTHOCORD DEVICE THAT DURING AN ACHILLES TENDON REPAIR OF THE RIGHT ANKLE ON (B)(6) 2018, IT WAS OBSERVED THAT A CALCANEAL FRACTURE OCCURRED WHEN INSERTING THE ANCHOR. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13337921 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF THE PRODUCT HEALIX TI WITH ORTHOCORD DEVICE THAT DURING AN ACHILLES TENDON REPAIR OF THE RIGHT ANKLE ON (B)(6) 2018, IT WAS OBSERVED THAT A CALCANEAL FRACTURE OCCURRED WHEN INSERTING THE ANCHOR. ACCORDING TO THE REPORT, AT FOUR WEEKS POST-OP ON (B)(6) 2018, X-RAYS DEMONSTRATED A NEW FRAGMENT OF BONE THAT DISPLACED, SEPARATE FROM THE INTRA-OPERATIVE MEDIAL CALCANEAL FRACTURE THAT OCCURRED DURING INSERTION OF THE VERSALOK ANCHOR. IT WAS FURTHER REPORTED THAT THE PATIENT HAD POSTOPERATIVE PAIN ON (B)(6) 2018. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13337862 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH REPORT ON CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF THE 4.5 HEALIX TI 3SUTURE ANCHOR W/OC DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR SURGERY OF THE LEFT SHOULDER PERFORMED ON (B)(6) 2017, IT WAS OBSERVED THAT THE PATIENT HAD A RE-TEAR THAT REQUIRED A REVISION SURGERY PERFORMED ON (B)(6) 2017. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13018630 ↗
• InjuryDec 16, 2021Migration; Migration

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH REPORT ON CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF THE 4.5 HEALIX TI 3SUTURE ANCHOR W/OC DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR SURGERY OF THE RIGHT SHOULDER PERFORMED ON (B)(6) 2019, IT WAS REVEALED THROUGH AN MRI ON (B)(6) 2019 A DISPLACEMENT OF THE ANCHOR THAT REQUIRED A REVISION SURGERY PERFORMED ON (B)(6) 2019 FOR THE REMOVAL OF THE LOOSE ANCHORS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13018621 ↗
• InjuryDec 16, 2021Migration; Migration

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH REPORT ON CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF THE 4.5 HEALIX TI 3SUTURE ANCHOR W/OC DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR SURGERY OF THE LEFT SHOULDER PERFORMED ON (B)(6) 2019, IT WAS OBSERVED THAT THE ANCHOR PULLED OUT REQUIRED A REVISION SURGERY PERFORMED ON (B)(6) 2019 FOR THE REMOVAL OF THE LOOSE ANCHORS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13018619 ↗
• InjuryDec 16, 2021Migration; Migration

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH REPORT ON CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF THE 4.5 HEALIX TI 3SUTURE ANCHOR W/OC DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR SURGERY OF THE RIGHT SHOULDER PERFORMED ON (B)(6) 2019, IT WAS OBSERVED THAT THE DEVICE PULLED-OUT THAT REQUIRED A REVISION SURGERY PERFORMED ON (B)(6) 2019 FOR THE REMOVAL OF THE LOOSE ANCHORS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13018614 ↗
• MalfunctionOct 19, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT A HAIR-LIKE FOREIGN BODY WAS FOUND IN THE VACUUM PACKAGE OF THE 4.5 HEALIX TI 3SUTURE ANC W/OC DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12659199 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED THAT THE ORTHOCORD THREADS SPLIT UP WHILE KNOT TYING AND KNOT TYING IS NO LONGER POSSIBLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7753614 ↗
• MalfunctionJun 25, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE THAT THE DEVICE WAS USED FOR DELTOID. THE 2.9MM DRILL WAS USED TO MAKE FORAMEN AND THEN THE ANCHOR WAS USED. DURING INSERTION, THE ANCHOR WAS BROKEN. THE BROKEN PART OF THE ANCHOR WHICH HAD ALREADY BEEN INSERTED IN THE BONE COULD NOT BE REMOVED FROM THE PATIENT¿S BONE. THE SURGERY WAS COMPLETED WITH THE BROKEN ANCHOR LEFT IN THE BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7634317 ↗