Arthrex® AR-300SRRecalls & reported problems

Arthrex, Inc. · SAW ATTACHMENT - RECIPROCATING · 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 00888867100268), received between Aug 20, 2025 and Aug 20, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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

Physical Resistance/Sticking1

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.

MalfunctionAug 20, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 08/05/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-300SR SAW ATTACHMENT RECIPROCATING WAS NOT WORKING PROPERLY, IT GETS STUCK. THIS OCCURRED DURING A MINI CFS SYSTEM CASE THAT WAS COMPLETED USING ANOTHER DEVICE.
Patient problems: Insufficient Information
MAUDE report 22853118 ↗

Device details

UDI-DI	`00888867100268`
Brand	Arthrex®
Model	AR-300SR
Company	Arthrex, Inc.
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	Sep 19, 2024

Device type (GMDN): Bone/joint surgical power tool motorized handpiece/set, electric, reusable

An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a surgical procedure; it is not dedicated to dental procedures. It includes an electric motor and typically one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and may include a rechargeable battery or a control unit; the endpieces are not included. 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 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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