EXPEDIUM 310002155PRecalls & reported problems

Medos International Sàrl · POWERED INSTRUMENTS EXPEDIUM SYSTEM POLY DRIVER, SHAFT, QUICK COUPLING 5.5 · Class 1

All models of EXPEDIUM (291)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This is a Medos EXPEDIUM poly driver, a powered surgical screwdriver shaft used to insert bone screws during orthopedic procedures. The reports mostly describe the shaft twisting, bending, or snapping during use, with the screwdriver tip breaking off during screw insertion, and instruments breaking in hard, sclerotic bone. There are 52 reports, with no deaths and no injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 52
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10705034469492), received between Mar 29, 2018 and Aug 19, 2026 — classified as 52 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (28 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Twisted/Bent28
Break26
No Apparent Adverse Event2
Device Slipped1
Device-Device Incompatibility1
Material Deformation1

Patient problems

No Clinical Signs, Symptoms or Conditions33
Insufficient Information13
No Consequences Or Impact To Patient6
Not Applicable2

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 19, 2026Break
It was reported the screwdriver tip broke off during screw insertion. No patient harm. No surgical delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50319699 ↗
MalfunctionJul 31, 2026Break
Patient problems: Insufficient Information
MAUDE report 50105684 ↗
MalfunctionJul 31, 2026Break
Patient problems: Insufficient Information
MAUDE report 50105682 ↗
MalfunctionJul 31, 2026Break
Patient problems: Insufficient Information
MAUDE report 50105677 ↗
MalfunctionJul 31, 2026Break
Patient problems: Insufficient Information
MAUDE report 50105674 ↗
MalfunctionJul 31, 2026Break
Patient problems: Insufficient Information
MAUDE report 50105673 ↗
MalfunctionJul 31, 2026Break
It was reported that instruments broke during a revision case with sclerotic bone. No further information is provided.
Patient problems: Insufficient Information
MAUDE report 50105672 ↗
MalfunctionJul 31, 2026Break
Patient problems: Insufficient Information
MAUDE report 50105671 ↗
MalfunctionJul 31, 2026Break
Patient problems: Insufficient Information
MAUDE report 50105664 ↗
MalfunctionJul 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105172 ↗
MalfunctionApr 24, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE PWR XPDM POLY DRIVER, SHAFT WAS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24988556 ↗
MalfunctionMar 9, 2026Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVERS WERE STRIPPED. THERE WAS NO SURGICAL DELAY OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24546980 ↗
MalfunctionMar 9, 2026Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVERS WERE STRIPPED. THERE WAS NO SURGICAL DELAY OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24546963 ↗
MalfunctionJul 2, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE DEVICE WAS RECEIVED AS BLIND UNIT. IT COULD NOT BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. DURING MANUFACTURER'S PRELIMINARY INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE TIP OF THE DEVICE WAS DAMAGED/STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22383703 ↗
MalfunctionMar 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE FOLLOWING DEVICE WAS RECEIVED FOR ANALYSIS: (B)(6), LOT NO - KM865871. THERE WAS NO PRODUCT MALFUNCTION OR PATIENT HARM REPORTED WITH THE RETURNED DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21564638 ↗
MalfunctionJan 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON UNKNOWN DATE THE DRIVERS STRIPPED DURING SCREW REMOVAL. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21143237 ↗
MalfunctionJan 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON UNKNOWN DATE THE DRIVERS STRIPPED DURING SCREW REMOVAL. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21143194 ↗
MalfunctionDec 3, 2024Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE TIPS OF TWO DRIVERS BROKE INSIDE THE SCREWS. THE SCREWS WERE REMOVED FROM THE PATIENT AND NEW ONES WERE INSERTED. OTHER SCREW DRIVERS WERE USED TO SUCCESSFULLY COMPLETE THE SURGERY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20835820 ↗
MalfunctionDec 3, 2024Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE TIPS OF TWO DRIVERS BROKE INSIDE THE SCREWS. THE SCREWS WERE REMOVED FROM THE PATIENT AND NEW ONES WERE INSERTED. OTHER SCREW DRIVERS WERE USED TO SUCCESSFULLY COMPLETE THE SURGERY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20835787 ↗
MalfunctionOct 29, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVERS STRIPPED DURING SCREW INSERTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20558979 ↗
MalfunctionOct 29, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVERS STRIPPED DURING SCREW INSERTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20558717 ↗
MalfunctionOct 1, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRIVER WAS STRIPPED DURING SCREW INSERTION. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20344471 ↗
MalfunctionSep 26, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE IN 2024, THE DRIVER WAS STRIPPED DURING SCREW INSERTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY. NO FRAGMENT GENERATED. THIS REPORT IS FOR A PWR XPDM POLY DRIVER, SHAFT.
Patient problems: Insufficient Information
MAUDE report 20310900 ↗
MalfunctionSep 26, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE DRIVER WAS STRIPPED DURING SCREW INSERTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY. NO FRAGMENT GENERATED. THIS REPORT IS FOR A PWR XPDM POLY DRIVER, SHAFT.
Patient problems: Insufficient Information
MAUDE report 20310698 ↗
MalfunctionSep 26, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE IN 2024, THE DRIVER WAS STRIPPED DURING SCREW INSERTION. PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR A PWR XPDM POLY DRIVER, SHAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20310409 ↗

Device details

UDI-DI	`10705034469492`
Brand	EXPEDIUM
Model	310002155P
Company	Medos International Sàrl
Product code	HWE · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Screwing power tool attachment

A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a powered screw insertion function when an appropriate screwdriver bit is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

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All INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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