ACUMED 80-0598Recalls & reported problems

Acumed LLC · 1.5mm Easyout, QR · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10806378043291), received between Jan 16, 2026 and Jan 16, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Material Fragmentation1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryJan 16, 2026Material Fragmentation
IT WAS REPORTED THAT DURING A REMOVAL SURGERY, TWO 1.5 HEX DRIVERS WERE USED TO REMOVE THE 2.3 SCREWS FROM THE PLATE AND BROKE IN THE PROCESS. THE 1.5 EASY OUT WAS ALSO USED TO REMOVE THE SAME SCREWS AND WAS DAMAGED IN THE PROCESS AS WELL. A SCREW REMOVAL SET, SCHULA AND METAL CUTTERS WERE USED TO COMPLETE THIS PROCEDURE. THERE WAS A REPORTED DELAY OF 30-40 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24100237 ↗

Device details

UDI-DI	`10806378043291`
Brand	ACUMED
Model	80-0598
Company	Acumed LLC
Product code	LXH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 15, 2020

Device type (GMDN): General internal orthopaedic fixation system implantation kit

A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

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All ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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