Arthrex® AR-8380DSRecalls & reported problems

Arthrex, Inc. · DISSECTOR, 3.8MM X 13CM · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867043367), received between Jul 15, 2024 and Jul 15, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Defective Device1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionJul 15, 2024Defective Device; Defective Device
ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8380DS DISSECTOR CONTAINS A PLASTIC IN THE SHAVER TIP BODY. THIS OCCURRED DURING A MENISCECTOMY.
Patient problems: Insufficient Information
MAUDE report 19739903 ↗

Device details

UDI-DI	`00888867043367`
Brand	Arthrex®
Model	AR-8380DS
Company	Arthrex, Inc.
Product code	GFA · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 4, 2022

Device type (GMDN): Arthroscopic shaver system, electrically-powered

A dedicated assembly of electrically-powered devices designed for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It typically consists of a power supply/control unit with operational display and dedicated software, intended to provide optimal parameters for the procedure, and a rotatory handpiece(s) that can operate a variety of burs and blades (either straight or curved) or other rotatory instruments. An irrigation system may be included. Common procedures include cartilage debridement (e.g., meniscus repair or meniscectomy) and removal of the inflamed inner lining of the joint (synovectomy). This is a reusable device.

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All BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL 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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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