Arthrex® AR-613-106Recalls & reported problems

Arthrex, Inc. · iBALANCE TKA, NOTCH PREP GUIDE, SIZE 6 · Class 1

Data updated Oct 18, 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 00888867116016), received between Jun 14, 2021 and Jun 14, 2021 — classified as 1 malfunction.

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 18, 2026.

Most reported problems

Device problems

Break1

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.

MalfunctionJun 14, 2021Break
IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE SURGEON WAS USING THE QUICK CONNECT TO GET CAGE OFF OF FEMUR, THE ADAPTOR PART BROKE. ALL FRAGMENTS WERE RECEIVED AND THE CASE WAS COMPLETED BY USING A NEW AR-613-106.
Patient problems: Insufficient Information
MAUDE report 11991320 ↗

Device details

UDI-DI	`00888867116016`
Brand	Arthrex®
Model	AR-613-106
Company	Arthrex, Inc.
Product code	LXH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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	Feb 23, 2024

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.

Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices

AML EXCEL 2001-42-000
Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
2,009 reports
NA 03.010.523
Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
1,208 reports
EXPRESSEW 214141
Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
1,166 reports
N/A 9560524
Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
866 reports
INHANCE 6500-11-104
Depuy (Ireland) · Orthopedic manual surgical instrument
831 reports
INHANCE 6500-11-102
Depuy (Ireland) · Orthopedic manual surgical instrument
567 reports
R3 71364450
Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
520 reports
N/A 9561524
Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
494 reports

All ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 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.

How reports and recalls are matched · Editorial policy · Report an error on this page