Q-FIX 72290119Recalls & reported problems

Smith & Nephew, Inc. · 1.8 MM QFIX REUSABLE CURVED DRILL GUIDE, XL · Class 1

All models of Q-FIX (21)

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 00885556657454), received between Feb 28, 2018 and Feb 28, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Compatibility Problem” (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

Compatibility Problem1
Patient-Device Incompatibility1

Patient problems

Injury1

Recent adverse event reports

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

InjuryFeb 28, 2018Patient-Device Incompatibility; Compatibility Problem
IT WAS REPORTED THAT Q-FIX DRILL GUIDE SLOT WAS WIDER THAN THE DIAMETER OF THE DRILL BIT, CAUSING THAT SURGEON DRILLED A HOLE IN HIS FINGER. NO UNIT TO RETURN.
Patient problems: Injury
MAUDE report 7304657 ↗

Device details

UDI-DI	`00885556657454`
Brand	Q-FIX
Model	72290119
Company	Smith & Nephew, Inc.
Product code	HTW · BIT, DRILL
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	Sep 7, 2023

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 BIT, DRILL devices

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770 reports
QUICKSET 2274-30-500
Depuy Orthopaedics, Inc. · BIT, DRILL
761 reports
NA 03.037.022
Synthes GmbH · BIT, DRILL
339 reports
NA 323.062
Synthes GmbH · BIT, DRILL
309 reports
QUICKSET 2274-56-000
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275 reports
QUICKSET 2274-45-500
Depuy Orthopaedics, Inc. · BIT, DRILL
211 reports
LCS 2366-83-000
Depuy (Ireland) · BIT, DRILL
207 reports

All BIT, DRILL 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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