ACUMED 80-0759Recalls & reported problems

Acumed LLC · T8 Stick Fit Hexalobe Driver · Class 1

Data updated Oct 13, 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 10806378044540), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 injury.

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. 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

Material Fragmentation1

Patient problems

Device Embedded In Tissue or Plaque1

Recent adverse event reports

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

InjuryMar 30, 2026Material Fragmentation
THE FOLLOWING WAS REPORTED: "ROYAL DEVON AND EXETER HAVE REPORTED A T8 SCREWDRIVER SNAPPING DURING A CASE. I SPOKE TO THE SURGEON WHO DID IT AND SHE SAID SHE DIDN'T PUT ANY EXTRA FORCE TO CAUSE IT TO BREAK. UNFORTUNATELY, WHERE IT SNAPPED, PART OF THE SCREWDRIVER WAS LEFT IN THE SCREW HEAD. THEY HAD TO LEAVE THIS IN THE PATIENT AS I THEY COULD NOT REMOVE IT AT THE TIME.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24732951 ↗

Device details

UDI-DI	`10806378044540`
Brand	ACUMED
Model	80-0759
Company	Acumed LLC
Product code	LXH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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	Mar 29, 2018

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 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices

AML EXCEL 2001-42-000
Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
2,009 reports
NA 03.010.523
Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
1,208 reports
EXPRESSEW 214141
Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
1,166 reports
N/A 9560524
Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
866 reports
INHANCE 6500-11-104
Depuy (Ireland) · Orthopedic manual surgical instrument
831 reports
INHANCE 6500-11-102
Depuy (Ireland) · Orthopedic manual surgical instrument
567 reports
R3 71364450
Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
520 reports
N/A 9561524
Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
494 reports

All ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page