NA 02.226.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982057860), received between Feb 13, 2018 and Feb 13, 2018 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K050636, K161616); they may or may not involve this specific model.

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.

• InjuryFeb 13, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A 3.0 MM HEADLESS COMPRESSION SCREW AND THREE (3) OTHER UNKNOWN SYNTHES SCREWS ON AN UNKNOWN DATE AT THE FIRST PROXIMAL PHLANGE. PATIENT COMPLAINED OF PAIN ON AN UNKNOWN DATE ALONG NOTICEABLE VISIBILITY OF THE SCREW PRESSING UPON THE SKIN. X-RAYS WERE TAKEN ON AN UNKNOWN DATE SHOWING ONE OF THE FOUR SCREWS BACKING OUT. PATIENT UNDERWENT SURGERY ON (B)(6) 2018 TO REMOVE THE ONE SCREW THAT WAS BACKING OUT. THE SCREW WAS REMOVED EASILY. THE OTHER THREE (3) SCREWS HAD NO ISSUES AND REMAINED INTACT. ROUTINE INTRAOPERATIVE X-RAYS WERE TAKEN. THE PATIENT WAS NOT REVISED TO ANY ADDITIONAL HARDWARE AND HAD ACHIEVED UNION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN SYNTHES SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 3). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 7266926 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050636, K161616. One submission often covers many models, so check the product and lot details in each record.

• Z-0238-2019 · Sep 12, 2018 · Terminated
  3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-