NA 04.226.040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982121882), received between Jun 3, 2022 and Jun 3, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN URUGUAY AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CAMACHO, E., CRAVIOTTO, M., AND D'OLIVIERA, L. (2021), HOW TO MANAGE COMPLICATIONS RELATED TO THE USE OF INTRAMEDULLARY SCREWS IN METACARPAL FRACTURES: CASE SERIES, REVISTA IBEROAMERICANA DE CIRUGI´A DE LA MANO, VOL. 49, PAGES 4¿12 (URUGUAY) THE PRESENT STUDY AIMS TO PRESENT A CASE SERIES OF COMPLICATIONS RELATED TO INTRAMEDULLARY SCREWS IN METACARPAL FRACTURES WHICH REQUIRED SURGICAL REINTERVENTIONS, AND TO DESCRIBE THE TECHNIQUE USED TO SOLVE THESE INTERCURRENCES. FROM 2016 TO 2019, A TOTAL OF 3 COMPLICATIONS WERE REPORTED IN 45 PATIENTS WITH METACARPAL FRACTURES SUBMITTED TO SURGICAL TREATMENT. THE MEAN AGE OF THE PATIENTS WITH COMPLICATIONS WAS 23 YEARS. THESE PATIENTS WERE TREATED WITH INTRAMEDULLARYSCREWS FOR STABILIZATION. IMPLANTS USED WERE INTRAMEDULLARY HEADLESS COMPRESSION SCREWS (HCSS, DEPUY SYNTHES, RAYNHAM, MA , US). THE PATIENTS WERE FOLLOWED UP FROM 2 MONTHS TO 3 YEARS AFTER SURGERY, WITH A MEAN FOLLOW-UP OF 6 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A 31-YEAR-OLD MALE PATIENT HAD BONY PROTRUSION AND IN

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 14598352 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CAMACHO, E., CRAVIOTTO, M., AND D'OLIVIERA, L. (2021), HOW TO MANAGE COMPLICATIONS RELATED TO THE USE OF INTRAMEDULLARY SCREWS IN METACARPAL FRACTURES: CASE SERIES, REVISTA IBEROAMERICANA DE CIRUGI´A DE LA MANO, VOL. 49, PAGES 4¿12 (URUGUAY) THE PRESENT STUDY AIMS TO PRESENT A CASE SERIES OF COMPLICATIONS RELATED TO INTRAMEDULLARY SCREWS IN METACARPAL FRACTURES WHICH REQUIRED SURGICAL REINTERVENTIONS, AND TO DESCRIBE THE TECHNIQUE USED TO SOLVE THESE INTERCURRENCES. FROM 2016 TO 2019, A TOTAL OF 3 COMPLICATIONS WERE REPORTED IN 45 PATIENTS WITH METACARPAL FRACTURES SUBMITTED TO SURGICAL TREATMENT. THE MEAN AGE OF THE PATIENTS WITH COMPLICATIONS WAS 23 YEARS. THESE PATIENTS WERE TREATED WITH INTRAMEDULLARYSCREWS FOR STABILIZATION. IMPLANTS USED WERE INTRAMEDULLARY HEADLESS COMPRESSION SCREWS (HCSS, DEPUY SYNTHES, RAYNHAM, MA , US). THE PATIENTS WERE FOLLOWED UP FROM 2 MONTHS TO 3 YEARS AFTER SURGERY, WITH A MEAN FOLLOW-UP OF 6 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) MALE PATIENT HAD BONY PROTRUSION AND INTENSE

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 14598351 ↗

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-