EXPEDIUM 310002160PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034469508), received between Aug 18, 2023 and Mar 13, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 13, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON FEBRUARY 26 2024, THE SCREWDRIVER DISTAL END TIP WAS STRIPPED AND THE SLEEVE NO LONGER ENGAGED WITH THE SCREW HEAD CORRECTLY. THE PATIENT WAS NOT IMPACTED AS A NEW SCREWDRIVER FROM ANOTHER SET WAS USED. THERE WAS NO DELAY IN SURGERY. THIS REPORT IS FOR ONE PWR XPDM POLY DRIVER, SLEEVE THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895601 ↗
• MalfunctionAug 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CANADA REPORTS AN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING CASE SETUP, THE NURSE NOTICED THAT THE POWER POLY DRIVER SLEEVE IN QUESTION WAS NOT PROPERLY HOLDING ONTO THE SCREWDRIVER. THE SLEEVE WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED USING THE OTHER SLEEVE IN THE SET. THERE WAS NO ADVERSE PATIENT IMPACT, NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, NO FRAGMENTS WERE GENERATED. NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A POWERED INSTRUMENTS EXPEDIUM SYSTEM POLY DRIVER, SLEEVE 5.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573026 ↗