HEALIX TRANSTEND ORTHOCORD PERCANNULA 222268Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705008148), received between Jul 16, 2018 and Mar 23, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SURGEON THAT POSTOPERATIVELY TO AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON (B)(6) 2015, IT WAS OBSERVED THAT THE PATIENT SUFFERED A POST-OPERATIVE TENDON TEAR ON (B)(6) 2016 AND WAS RE-OPERATED ON (B)(6) 2017. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11553935 ↗
• MalfunctionJul 16, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT HIS HEALIX ANCHOR BROKE IN HALF UPON INSERTION INTO THE BONE DURING A BICEP PROCEDURE. THE SURGEON TOOK ALL BROKEN COMPONENTS OUT OF THE BONE HOLE AND INSERTED ANOTHER LIKE ANCHOR TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP STATED HE BELIEVED IT WAS DUE TO VERY HARD BONE. THE SURGEON WAS FAMILIAR WITH HEALIX ANCHORS. THE COMPLAINT DEVICE WAS ALREADY DISCARDED BY THE CUSTOMER. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7692770 ↗