NA 316.294Recalls & reported problems

Synthes GmbH · 0.76MM DRILL BIT MINI QC WITH 14MM STOP/44.5MM · Class 1

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 10886982189615), received between Jan 24, 2024 and Jan 24, 2024 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Break1

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.

MalfunctionJan 24, 2024Break; Break
THE BREAKAGE OCCURRED INTRAOPERATIVELY WITH PROPER USE ACCORDING TO THE TECHNIQUE GUIDE.
Patient problems: Insufficient Information
MAUDE report 18572859 ↗

Device details

UDI-DI	`10886982189615`
Brand	NA
Model	316.294
Catalog no.	316294
Company	Synthes GmbH
Product code	HSZ · Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment
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 29, 2022

Device type (GMDN): Fluted surgical drill bit, reusable

A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.