NA 1896-4028SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540202338), received between Dec 22, 2020 and May 11, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Positioning Failure

  DURING T2PH SURGERY, THE SCREW PLACED IN THE MOST DISTAL OVAL HOLE PROTRUDED ANTERIORLY BEYOND THE BONE. AS THE EVENT OCCURRED AFTER SCREW INSERTION INTO THE DISTAL ROUND HOLE, THE SCREW PLACED IN THE DISTAL OBLONG HOLE WAS REMOVED FROM THE BODY. SINCE ONE SCREW REMAINS INSERTED DISTALLY, THE PHYSICIAN ASSESSED THAT STABLE FIXATION HAD BEEN ACHIEVED. UPON INSPECTION OF THE TARGETING DEVICE AT THE JAPAN DISTRIBUTION CENTER, IT WAS CONFIRMED THAT THE DRILL INTERFERES WITH THE NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25138086 ↗
• InjuryDec 22, 2020Migration; Migration

  AS REPORTED: "THE INDICATION WAS LEFT UPPER ARM BONE FRACTURE. AFTER THE INITIAL OPERATION(PERFORMED ON (B)(6) 2020), ON (B)(6) 2020, DURING CLINICAL OBSERVATION THE BACK OUT OF THE SCREW WAS FOUND OUT IN X-RAYS. IT IS JUDGED THAT THE BONE UNION HAS NOT BEEN ACHIEVED AND THE UNION WAS POOR. SO, THE SCREW WAS REMOVED AND REINSERTED WITH ANOTHER SCREW ON THE SAME DATE. THE PROCEDURE COMPLETED WITHOUT PROBLEM.".

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 11060355 ↗
• InjuryDec 22, 2020Migration; Migration

  AS REPORTED: "THE INDICATION WAS LEFT UPPER ARM BONE FRACTURE. AFTER THE INITIAL OPERATION(PERFORMED ON (B)(6) 2020). ON (B)(6) 2020, DURING CLINICAL OBSERVATION THE BACK OUT OF THE SCREW WAS FOUND OUT IN X-RAYS. IT IS JUDGED THAT THE BONE UNION HAS NOT BEEN ACHIEVED AND THE UNION WAS POOR. SO, THE SCREW WAS REMOVED AND REINSERTED WITH ANOTHER SCREW ON THE SAME DATE. THE PROCEDURE COMPLETED WITHOUT PROBLEM."

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 11060344 ↗