FlowerToe Cannulated, D:2.0mm x 13mm FHT 200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840118114035), received between Mar 9, 2021 and Mar 9, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionMar 9, 2021Fracture; Fracture

  "IN A PHONE CALL ON (B)(6) 2021, (B)(6) NOTED THAT TWO IMPLANTS BROKE DURING DR. (B)(6) CASE. THE FIRST BROKEN IMPLANT WAS DESCRIBED AS SNAPPING WHEN IT WAS BEING SCREWED IN, SPECIFICALLY AT THE HEAD OF THE IMPLANT WHERE "IT'S CONNECTED TO WHERE IT'S BROACHED." THIS IMPLANT WAS DISPOSED OF AND A NEW IMPLANT WAS EFFECTIVELY USED. THE SECOND IMPLANT ALSO BROKE IS A SIMILAR LOCATION WHEN TRYING TO SCREW IN THE IMPLANT. (B)(6) ALSO NOTED THAT THE IMPLANT TIP APPEARED BROKEN. HOWEVER, THE METAL THREADING WAS DESCRIBED AS ALSO "UNRAVELING" AND "DISINTEGRATING." THIS METAL THREADING CAME OFF OF THE IMPLANT AND WAS LODGED IN THE PATIENT. THE DOCTOR MADE AN INCISION NEAR THE IMPLANT SITE AND WAS ABLE TO SUCCESSFULLY REMOVE THE METAL THREADING WITHOUT USING X-RAY. THE DOCTOR WAS FRUSTRATED DUE TO THE TWO EVENTS AND ENDED UP USING K-WIRES FOR FIXATION AS AN ALTERNATIVE. IT WAS NOTED THAT THE SURGERY TIME INCREASED FROM 1.5-2 H TO 3.5-4 H DUE TO THE TWO EVENTS. HOWEVER, THE PATIENT WAS NOTED TO HAVE NO ADVERSE EVENTS AS OF THEIR FOLLOW-UP VISIT ON (B)(6) 2021. DR. (B)(6) DESCRIBED THE IMPLANTS AS BEING VERY "DELICATE" AND RECOMMENDED CREATING A MORE FLEXIBLE IMPLANT DESIGN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445543 ↗