Q-FIX 72205694Recalls & reported problems

Smith & Nephew, Inc. · 2.9MM CANNULATED DRILL FOR Q-FIX ULTRA & 1.25MM DRILL PIN · 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: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556890790), received between Jun 16, 2025 and Jun 16, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

Material Deformation1

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.

MalfunctionJun 16, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT, DURING A PROCEDURE, THE DOCTOR DRILLED OVER THE GUIDE WIRE THAT COMES WITH THE CANNULATED Q-FIX ULTRA DRILL. THE DRILL WAS SLIGHTLY BENT DUE TO HARD BONE WHICH WASN'T EASILY SEEN VIA X-RAY AND IT WAS DAMAGED. THIS CAUSED WIDENING OF THE DRILLED HOLE, AND A LARGER ANCHOR BACK-UP DEVICE HAD TO BE USED IN THE TALUS TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22211286 ↗

Device details

UDI-DI	`00885556890790`
Brand	Q-FIX
Model	72205694
Company	Smith & Nephew, Inc.
Product code	HTW · BIT, DRILL
Class	Class 1
FDA submission	K232457
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 6, 2024

Device type (GMDN): Cannulated surgical drill bit, single-use

A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.

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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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