HEALIX TRANSTEND ORTHOCORD PERCANNULA 222278Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705020300), received between Dec 1, 2017 and Jul 16, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2018Break; Break

  THE SALES REP REPORTED THAT DURING A SHOULDER REPAIR HIS HEALIX TRANSEND PEEK IMPLANT BROKE IN HALF. THE SALES REP REPORTED THAT DUE TO UNDUE TORQUE ON THE TIP OF THE ANCHOR INSIDE THE CANNULA CAUSED THE IMPLANT TO BREAK. THE SALES REP REPORTED THERE WAS ALLOT OF RESISTANCE DURING THE INSERTION INTO THE BONE HOLE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE IMPLANT WAS ALREADY DISCARDED BY THE CUSTOMER. THE SALES REP STATED THE BONE QUALITY WAS NORMAL. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7692821 ↗
• MalfunctionDec 1, 2017Break; Break

  DR. XXXX WAS USING DEPUY MITEK HEALIX TRANSTEND PEEK ANCHOR #222276 (X2) AND DEPUY MITEK HEALIX TRANSTEND (PEEK1) IMPLANT SYSTEM (X2) TO REPAIR A PATELLA TENDON AND THEY ALL BROKE. ENDED UP USING A ARTHREX PRODUCT. PER ADDITIONAL INFORMATION PROVIDED BY THE SALES REP ON DECEMBER 26, 2017: I BELIEVE MOST OF THESE WERE ANSWERED IN MY INITIAL REPORT. ALL DEVISES WERE DISCARDED DURING SURGERY AND NOT AVAILABLE TO GET LIT NUMBERS BY THE TIME THEY WERE REPORTED TO ME. I WAS NOT AT THE CASE. THE DEVISES WERE USED DURING THE CASE AND THE ALTERNATES WERE THE OTHER ONES THAT BROKE UNTIL THE DECIDED TO USE ANOTHER BRAND PRODUCT. I WILL ASK HOW MUCH DELAY THERE WAS BUT I WOULD IMAGINE IT WAS MORE THAN 30 MIN SINCE THEY WENT THRU 5 PRODUCTS. NO PRICES LEFT IN THE PATIENT. SURGERY WAS COMPLETED. ACCORDING TO THEM THE PROCEDURE WAS DONE CORRECTLY. PER ADDITIONAL INFORMATION PROVIDED BY THE SALES REP ON DECEMBER 26, 2017: THE CHARGE NURSE INDICATED THERE WAS NO DELAY AND NOTHING LEFT IN. SHE ALSO SAID SHE MAY HAVE PICTURES OF THE BOXES WITH THE SERIAL NUMBER. PER ADDITIONAL INFORMATION PROVIDED BY THE SALES REP ON DECEMBER 27, 2017: THE DELAY WAS ABOUT 15 MINUTES. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7076449 ↗