Drills DRILL-4.0CLRecalls & reported problems

Trimed, INC. · Drill 4.0, 220mm Cannulated · Class 1

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 00842188109881), received between Aug 2, 2018 and Aug 2, 2018 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Break1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

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

InjuryAug 2, 2018Break; Break
TRIMED RECEIVED THE FOLLOWING REPORT ON 03 JUL 2018 FROM TRIMED SALES MEMBER LOCATED IN THE (B)(4), REGARDING THE DRILL 4.0, 220 MM CANNULATED: DURING A INTRA-OPERATIVE PROCEDURE, IT WAS DISCOVERED THAT THE DRILL 4.0, 220 MM CANNULATED (DRILL-4.0 CL) HAD MALFUNCTIONED ONCE IT MADE CONTACT WITH THE BONE. THE BONE QUALITY WAS DETERMINED TO BE QUITE SCLEROTIC COMPARED TO USUAL. THIS INCIDENT DID NOT CAUSE ANY FURTHER HARM TO THE PATIENT. THIS IS THE FIRST TIME THIS TYPE OF MALFUNCTION HAS BEEN REPORTED TO TRIMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7742605 ↗

Device details

UDI-DI	`00842188109881`
Brand	Drills
Model	DRILL-4.0CL
Company	Trimed, INC.
Product code	HTW · BIT, DRILL
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 15, 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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