Arthrex® AR-8717G-02Recalls & reported problems

Arthrex, Inc. · DynaNite® Staple Drill Guide, 13 / 15 mm · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867326101), received between Apr 25, 2024 and May 24, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 reports).

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

Physical Resistance/Sticking3

Patient problems

No Clinical Signs, Symptoms or Conditions2
Insufficient Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2022, IT WAS REPORTED BY A DISTRIBUTOR VIA PHONE THAT ON (B)(6) 2022 DURING A 4 CORNER FUSION A AR-8717DS-1110 DYNANITE STAPLE IMPLANT SYSTEMS DRILL BIT GOT BOUND UP IN THE DRILL GUIDE. THEN FOLLOWING THIS AN AR-8717DS-0910 DYNANITE STAPLE IMPLANT SYSTEMS DRILL BIT ALSO GOT BOUND UP IN THE DRILL GUIDE. THE SURGEON PROCEEDED TO GET 2 NEW KITS AND THOSE WORKED ACCORDINGLY. A AR-8717G-01 DRILL GUIDE, AND A AR-8717G-02 DRILL GUIDE ALSO GOT BOUND UP. THE CASE WAS COMPLETED HOWEVER THE SURGEON WAS NOT PLEASED WITH THE PLACEMENT.
Patient problems: Insufficient Information
MAUDE report 19397566 ↗
MalfunctionMay 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 8/19/2021 IT WAS REPORTED BY SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8717D-02 GOT STUCK IN THE DRILL GUIDE AR-8717G-02 SIDE "15" DURING A CASE. THIS OCCURRED AGAIN DURING ANOTHER PROCEDURE, WHERE AR-8717D-02 GOT STUCK IN THE DRILL GUIDE AR-8717G-02 SIDE "13". NO PATIENT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19319259 ↗
MalfunctionApr 25, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT WHEN DRILLING FROM THE GUIDE SLEEVE PART, IT DID NOT PROCEED SMOOTHLY. THE CONTACT AREA AT THE BASE OF THE DRILL HAD A SCORCHED MARK. A NEW GUIDE AND DRILL WAS OPENED AND USED TO COMPLETE THE CASE WITH NO ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19185872 ↗

Device details

UDI-DI	`00888867326101`
Brand	Arthrex®
Model	AR-8717G-02
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	Apr 6, 2020

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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