DJO SURGICAL 801-01-042Recalls & reported problems

Encore Medical, L.P. · SCREW DRIVER, HEX HEAD · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912127165), received between Aug 25, 2020 and Sep 11, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 18, 2026.

Most reported problems

Device problems

Naturally Worn1
Peeled/Delaminated1
Therapeutic or Diagnostic Output Failure1

Patient problems

Device Embedded In Tissue or Plaque1
Insufficient Information1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 11, 2020Naturally Worn; Therapeutic or Diagnostic Output Failure
INSTRUMENT FAILURE - THE HEX HEAD IS WORN OUT.
Patient problems: Insufficient Information
MAUDE report 10523285 ↗
MalfunctionAug 25, 2020Peeled/Delaminated
INSTRUMENT FAILURE - THE SCREW DRIVER TIPS ARE SLIGHTLY STRIPPED OUT AND CAUSED THE PERIPHERAL SCREWS ON THE BASEPLATE TO BE STRIPPED OUT. THERE ARE STRIPPED SCREWS LEFT IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10448778 ↗

Device details

UDI-DI	`00888912127165`
Brand	DJO SURGICAL
Model	801-01-042
Company	Encore Medical, L.P.
Product code	HXX · SCREWDRIVER
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 3, 2023

Device type (GMDN): Orthopaedic prosthesis implantation positioning instrument, reusable

A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Other SCREWDRIVER devices

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Medtronic Sofamor Danek, Inc. · SCREWDRIVER
492 reports
QUICKSET 2274-47-000
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487 reports
NA 03.130.010
Synthes GmbH · SCREWDRIVER
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404 reports
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Smith & Nephew, Inc. · SCREWDRIVER
336 reports

All SCREWDRIVER 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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