VARIAX 703883Recalls & reported problems

Stryker GmbH · Drill Guide, Comp,Polyax 2.0mm Drill, T10 · Class 1

All models of VARIAX (345)

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 07613327069938), received between Apr 28, 2023 and Apr 28, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (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

Degraded1

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.

MalfunctionApr 28, 2023Degraded; Degraded
AS REPORTED: "ORIF FOR LEFT CLAVICLE WAS PERFORMED. WHEN AN OPERATING ROOM STAFF CHECKED THE USED INSTRUMENTS AFTER POSTOPERATIVE CLEANING, IT WAS FOUND THAT COLOR PAINT (GREEN OR ORANGE) OF THE TWO DRILL GUIDES (CAT#703882, 703883) HAD PEELED OFF. IT WAS UNKNOWN WHEN THE PAINTS PEELED OFF."
Patient problems: Insufficient Information
MAUDE report 16837870 ↗

Device details

UDI-DI	`07613327069938`
Brand	VARIAX
Model	703883
Company	Stryker GmbH
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	Apr 14, 2025

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
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866 reports
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Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
520 reports
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Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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