NA 60.045.002Recalls & reported problems

Synthes GmbH · ADVANCED NAIL BASE TRAY OPENING AND INSERTION INSTR · Class 1

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 10886982299673), received between Oct 7, 2024 and Oct 7, 2024 — classified as 1 injury.

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

Appropriate Device Problem Term/Code Not Available1

Patient problems

Insufficient Information1

Recent adverse event reports

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

InjuryOct 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED ON (B)(6) 2024, 2/3 OF THE BASIC INSTRUMENTS OF THE TN ADVANCED WERE NOT SENT. THE EVENT WAS REPORTED BY THE TA WHEN THE PATIENT WAS ALREADY UNDER ANESTHESIA. IT SHOULD HAVE BEEN TAKEN OUT OF THE WAREHOUSE AS CODE BLUE TO BE DELIVERED.
Patient problems: Insufficient Information
MAUDE report 20385787 ↗

Device details

UDI-DI	`10886982299673`
Brand	NA
Model	60.045.002
Catalog no.	60045002
Company	Synthes GmbH
Product code	FSM · TRAY, 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	Jul 14, 2022

Device type (GMDN): Surgical instrument/implant rack

A device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.