N/A 61015Recalls & reported problems

Artelon · Cannulated Drill Bit · 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 00850003396279), received between Dec 16, 2024 and Dec 16, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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

Device Difficult to Setup or Prepare1

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.

InjuryDec 16, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
IT WAS REPORTED IN A PROCEDURE INVOLVING A 32-YEAR-OLD MALE PATIENT, A 4.5 DRILL BIT WAS SUCCESSFULLY USED ON THE TALUS. HOWEVER, WHEN USED ON THE FIBULA, THE ANCHOR PULLED OUT DUE TO SOFTER BONE IN THAT AREA. A 4.25 DRILL WAS USED TO CREATE A NEW HOLE IN A DIFFERENT LOCATION, WHICH WORKED GREAT.
Patient problems: Insufficient Information
MAUDE report 20938856 ↗

Device details

UDI-DI	`00850003396279`
Brand	N/A
Model	61015
Company	Artelon
Product code	HTW · Bit, Drill
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	Jan 29, 2025

Device type (GMDN): Cannulated surgical drill bit, single-use

A metal shaft 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) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.

Other Bit, Drill devices

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770 reports
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761 reports
NA 03.037.022
Synthes GmbH · BIT, DRILL
339 reports
NA 323.062
Synthes GmbH · BIT, DRILL
309 reports
QUICKSET 2274-56-000
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275 reports
QUICKSET 2274-45-500
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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