Drill Bit Kit, 3.0mm DBK 030Recalls & reported problems

Flower Orthopedics Corporation · surgical instrument or accessory for orthopedic bone fixation · Class 1

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 00840118104623), received between May 13, 2019 and May 13, 2019 — classified as 1 malfunction.

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

Material Fragmentation1

Patient problems

Discomfort1

Recent adverse event reports

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

MalfunctionMay 13, 2019Material Fragmentation; Material Fragmentation
DBK 030 BROKE, A PIECE WAS LEFT IN THE PATIENT. ACCORDING TO (B)(6) (SALES REP), THE DRILL BIT GOT STUCK WITHIN THE DRILL GUIDE AND BECAUSE THE DRILL BIT WAS STUCK, IT WARPED AND A PIECE OF THE DRILL BIT WAS BROKEN OFF AND LEFT WITHIN THE PATIENT. THE SURGEON HAD NO INTERFERENCE WHEN INSERTING THE SCREW WHERE THE DRILL BIT BROKE OFF AND THE CASE WENT ON.
Patient problems: Discomfort
MAUDE report 8605769 ↗

Device details

UDI-DI	`00840118104623`
Brand	Drill Bit Kit, 3.0mm
Model	DBK 030
Company	Flower Orthopedics Corporation
Product code	HTW · Bit, Drill
Class	Class 1
FDA submission	None listed
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	Jun 4, 2018

Device type (GMDN): Screwing power tool attachment

A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a powered screw insertion function when an appropriate screwdriver bit is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable 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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