Arthrex® AR-1610LGRecalls & reported problems

Arthrex, Inc. · LOCKING GUIDE · Class 1

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867241947), received between Dec 22, 2023 and Feb 8, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Incorrect Measurement” (2 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

Incorrect Measurement2

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Bone Fracture(s)1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryFeb 8, 2024Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT DURING A MENISCAL ROOT REPAIR SURGERY ON TWO SEPARATE ATTEMPTS THE DRILL CAME OUT 5MM MEDIALLY FROM THE POINT AT WHICH IT SHOULD HAVE COME OUT AS INDICATED BY THE 7.5MM OFFSET MARK ON THE HOOK. THIS LED TO AN UNNECESSARY LOSS OF TIBIA BONE IN THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-1610LG). IT WAS NECESSARY TO USE THE TIBIA ACL (HALO) JIG TO ACCURATELY DRILL THE TIBIA TUNNEL. UPDATE (B)(4) 11-JAN-2024: FURTHER INFORMATION REVEALED THAT AR-1610LG BATCH: 43212209 WAS ALSO INVOLVED IN THIS INCIDENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18666667 ↗
InjuryDec 22, 2023Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT DURING A MENISCAL ROOT REPAIR SURGERY ON TWO SEPARATE ATTEMPTS THE DRILL CAME OUT 5MM MEDIALLY FROM THE POINT AT WHICH IT SHOULD HAVE COME OUT AS INDICATED BY THE 7.5MM OFFSET MARK ON THE HOOK. THIS LED TO AN UNNECESSARY LOSS OF TIBIA BONE IN THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NECESSARY TO USE THE TIBIA ACL (HALO) JIG TO ACCURATELY DRILL THE TIBIA TUNNEL.
Patient problems: Bone Fracture(s)
MAUDE report 18387376 ↗

Device details

UDI-DI	`00888867241947`
Brand	Arthrex®
Model	AR-1610LG
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	Jul 28, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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