Arthrex® AR-13417-01Recalls & reported problems

Arthrex, Inc. · KEYHOLE GUIDE, LEFT · 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 00888867012431), received between Feb 24, 2025 and Feb 24, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

Break1

Patient problems

Foreign Body In Patient1

Recent adverse event reports

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

InjuryFeb 24, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13417-01 KEYHOLE GUIDE BROKE INSIDE THE PATIENT. THIS OCCURRED DURING USE IN A CASE, THE DEVICE WAS UNKNOWINGLY LEFT INSIDE THE PATIENT AND A REVISION SURGERY WAS NEEDED TO REMOVE. PER FACILITY: "ON FRIDAY (B)(6)2025 {SURGEON} PERFORMED AN INBALANCE HTO AT {HOSPITAL} WITH LOANER INSTRUMENT SET FROM ORDER NUMBER (B)(4). IN PERFORMING THE CASE WE DIDN'T REALIZE THAT THE LEFT SIDED KEYHOLE GUIDE (AR-13417-01) POSTERIOR LEG BROKE FOR AN UNKNOWN REASON. UNFORTUNATELY, THIS WAS NOT CAUGHT DURING THE REST OF THE CASE UNTIL THE FOLLOWING MORNING (B)(6)2025 WHEN {SURGEON} WAS ROUNDING ON THE PATIENT IN THE HOSPITAL WHEN THEY PERFORMED AN X-RAY AND FOUND THE BROKEN PIECE. THE PHOTOS ARE ATTACHED. WE THEN PERFORMED A 2ND SURGERY ON THIS PATIENT FOR REMOVAL OF THE RETAINED HARDWARE SATURDAY 2/8/25. ALTHOUGH WE DO NOT HAVE A GREAT REASON FOR WHY THE INSTRUMENT BROKE, WE DID NOTICE THE INSTRUMENT WAS MUCH MORE ¿WEATHERED¿ AND OLDER THAN THE RIGHT SIDED KEY-HOLE DRILL GUIDE. {SURGEON} WAS VERY UNDERSTANDING AND IN HINDSIGHT, WE SHOULD HAVE RECOGNIZED THE BROKEN PIECE IN X-RAYS TAKEN DURING THE REST OF THE CASE. THE RE
Patient problems: Foreign Body In Patient
MAUDE report 21445187 ↗

Device details

UDI-DI	`00888867012431`
Brand	Arthrex®
Model	AR-13417-01
Company	Arthrex, Inc.
Product code	MDM · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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	Nov 16, 2021

Device type (GMDN): Surgical drill guide, reusable

A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

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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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