MANTIS 48281167Recalls & reported problems

Stryker Corporation · CANNULATED MODULAR TAP · Class 1

All models of MANTIS (14)

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 07613327266603), received between Mar 14, 2016 and Mar 14, 2016 — 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 16, 2026.

Most reported problems

Device problems

Break1
Detachment Of Device Component1
Fracture1
Material Integrity Problem1

Patient problems

No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

MalfunctionMar 14, 2016Fracture; Material Integrity Problem; Break; Detachment Of Device Component; Fracture; Material Integrity Problem
IT WAS REPORTED THAT THE TIP ON THE SCREWDRIVER FOR CLOSED HEAD SCREWS SHEARED OFF FROM SCREWDRIVER UPON INSERTION OF SCREW INTO THE BONE. SCREW AND TIP WERE LEFT IN PLACE AND USED IN CONSTRUCT. THE TAP WAS BROKEN IN BONE UPON TAPPING THE BONE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5499062 ↗

Device details

UDI-DI	`07613327266603`
Brand	MANTIS
Model	48281167
Company	Stryker Corporation
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	Not in Commercial Distribution
Record updated	Mar 17, 2025

Device type (GMDN): Bone tap, reusable

A surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

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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 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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