ACUMED 80-0627Recalls & reported problems

Acumed LLC · 2.3mm Quick Release Drill · 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 10806378043574), received between Aug 28, 2025 and Aug 28, 2025 — 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.

Reports received per month

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

Most reported problems

Device problems

Material Fragmentation1

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.

MalfunctionAug 28, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED IN A CASE IN (B)(6) TODAY WHEN ALLEGEDLY A DRILL SNAPPED ON ONE OF THEIR NEW SETS (IT'S A SET THAT THEY'RE TRIALING SO IT WAS REPORTEDLY A LOAN ONE WAS USED). THE DRILL IS REPORTEDLY A 2.3MM QUICK RELEASE DRILL (CODE 80-0627). THERE WAS ALLEGEDLY NOT ANY DELAY CAUSED BY THIS DUE TO HAVING A SECOND DRILL ON THE SET, SO NO EFFECT ON OP (OPERATION) TIMES AND WON'T HAVE AN EFFECT ON PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22914489 ↗

Device details

UDI-DI	`10806378043574`
Brand	ACUMED
Model	80-0627
Company	Acumed 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 15, 2020

Device type (GMDN): General internal orthopaedic fixation system implantation kit

A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Other BIT, DRILL devices

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QUICKSET 2274-56-000
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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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