Arthrex® AR-13203-05Recalls & reported problems

Arthrex, Inc. · LOW PROFILE OSTEOTOME SHORT 5 MM · 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 00888867009783), received between Mar 16, 2017 and Mar 16, 2017 — 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.

Most reported problems

Device problems

Break1
Detachment Of Device Component1
Device Or Device Fragments Location Unknown1

Patient problems

Device Embedded In Tissue or Plaque1

Recent adverse event reports

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

InjuryMar 16, 2017Break; Detachment Of Device Component; Device Or Device Fragments Location Unknown
IT WAS REPORTED THAT A SMALL SHARD OF OSTEOTOME BROKE-OFF DURING OSTEOTOMY PROCEDURE AT LATERAL EDGE OF OSTEOTOMY. SURGEON WAS UNABLE TO LOCATE THE FRAGMENT SO IT WAS LEFT IN SITU AS IT IS IN A NON-CRITICAL PLACE WITHIN OSTEOTOMY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6411452 ↗

Device details

UDI-DI	`00888867009783`
Brand	Arthrex®
Model	AR-13203-05
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 30, 2021

Device type (GMDN): Orthopaedic osteotome

A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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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