Arthrex® AR-1530C-35-RURecalls & reported problems

Arthrex, Inc. · 3.5MM DRILL, CANNULATED, REUSABLE · Class 1

Data updated Oct 18, 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 00888867263932), received between Aug 12, 2024 and Aug 12, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Overheating of 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. 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

Overheating of Device1

Patient problems

Low Oxygen Saturation1
Osteolysis1

Recent adverse event reports

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

InjuryAug 12, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING SURGERY THE DRILL BIT CAUSED SIGNIFICANT HEATING WHEN USED AND CAUSED MAJOR OSTEOLYSIS WHICH LEAD TO SURGICAL REVISION. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Low Oxygen Saturation; Osteolysis
MAUDE report 19966143 ↗

Device details

UDI-DI	`00888867263932`
Brand	Arthrex®
Model	AR-1530C-35-RU
Company	Arthrex, Inc.
Product code	HTW · BIT, DRILL
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	Jun 22, 2021

Device type (GMDN): Cannulated surgical drill bit, reusable

A shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.

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All BIT, DRILL 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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