Arthrex® AR-1616-MRecalls & reported problems

Arthrex, Inc. · FINGER TRAP · Class 1

Data updated Oct 16, 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 00888867020108), received between Mar 12, 2026 and Mar 12, 2026 — 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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionMar 12, 2026Break
ON (B)(6), IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-(B)(4) THAT AN AR-1616-M MEDIUM FINGER TRAP BROKE DURING PLACEMENT FOR TRACTION. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH A SECOND UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24580964 ↗

Device details

UDI-DI	`00888867020108`
Brand	Arthrex®
Model	AR-1616-M
Company	Arthrex, Inc.
Product code	KQZ · COMPONENT, TRACTION, NON-INVASIVE
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	May 1, 2019

Device type (GMDN): Orthopaedic casting stand

A structure/frame designed to hold and support a patient's torso or limb (arm or leg) in an appropriate position during an orthopaedic casting procedure. It typically consists of an adjustable base/pedestal and frame with a set of detachable components including limb-positioning attachments to maintain optimum joint alignment, supports for resting limbs, and blades for forming the cast. Typically the body part is placed on a blade and the cast material is wrapped around it; after completing the cast, the blade is removed from the cast to provide space for improved blood circulation and patient comfort. This is a reusable device.

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All COMPONENT, TRACTION, NON-INVASIVE 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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