HEALIX TI PERMACORD 223141Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705024698), received between Sep 23, 2019 and Sep 23, 2019 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE INSERTER SHAFT AT THE END OF THE EDGE LINE OF THE DRIVER ON THE CUSTOMER'S 4.5MM HEALIX TI 3 SUTURE ANCHOR WITH PERMACORD BROKE NEAR THE WINDOW. THE BROKEN PIECE WAS REMOVED WITH GRASPERS AND THE ANCHOR WAS BACKED OUT WITH AN INSERTER. THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT HARM BUT A FIVE MINUTE SURGICAL DELAY TO THE CASE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9106237 ↗