3.5MM HEX RATCHET SHAFT 31-424202Recalls & reported problems

Data updated Oct 18, 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 00880304449831), received between Mar 11, 2026 and Mar 11, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Fracture1

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 11, 2026Fracture
IT WAS REPORTED THAT DURING SCREW INSERTION, THE HEX HEAD OF THE SCREWDRIVER BROKE. THERE WAS NO IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24574953 ↗

Device details

UDI-DI	`00880304449831`
Brand	3.5MM HEX RATCHET SHAFT
Model	31-424202
Company	Biomet Orthopedics, LLC
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	May 30, 2025

Device type (GMDN): Surgical instrument handle, non-torque-limiting

A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Other BIT, DRILL devices

QUICKSET 2274-25-500
Depuy Orthopaedics, Inc. · BIT, DRILL
1,985 reports
QUICKSET 2274-35-500
Depuy Orthopaedics, Inc. · BIT, DRILL
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
Depuy (Ireland) · BIT, DRILL
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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