NA 2598-07-160Recalls & reported problems

Depuy (Ireland) · MI SYSTEM NARROW COBRA · Class 1

Data updated Oct 18, 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 10603295148135), received between Sep 25, 2019 and Sep 25, 2019 — classified as 1 malfunction.

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 18, 2026.

Most reported problems

Device problems

Break1
Material Twisted/Bent1
Scratched Material1

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.

MalfunctionSep 25, 2019Break; Material Twisted/Bent; Scratched Material; Break; Material Twisted/Bent; Scratched Material
IT WAS REPORTED THAT THE TIP OF RETRACTOR HAS BEEN GROUND AWAY AFTER REPEATED INTERACTIONS WITH THE SAW BLADE DURING INTRA OPERATIVE BONE CUTS. REPLACEMENT TO MEMORIAL REGIONAL. IT WAS CHIPPED AWAY FROM COMING IN CONTACT WITH SAW BLADE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9117525 ↗

Device details

UDI-DI	`10603295148135`
Brand	NA
Model	2598-07-160
Catalog no.	259807160
Company	Depuy (Ireland)
Product code	GAD · RETRACTOR
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 28, 2026

Device type (GMDN): Hand-held surgical retractor, reusable

A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

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All RETRACTOR 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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