STAR 933-0003Recalls & reported problems

Stryker GmbH · Tibial Alignment Rotation Sleeve Assembly · Class 3

Data updated Oct 13, 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 00886385018812), received between Aug 29, 2019 and Aug 29, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Break1
Detachment of Device or Device Component1
Fracture1

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.

MalfunctionAug 29, 2019Break; Fracture; Detachment of Device or Device Component; Fracture
IT WAS REPORTED THAT THE STAR IMPLANT ITEM ON THE TIBIAL ALIGNMENT GUIDE WAS BROKEN. THE SCREW ON THE SLIDING BLOCK ON THE PROXIMAL END HAD BEEN SHEARED AND LEFT IN THE GUIDE, THIS MEANT IT WAS UNABLE TO BE USED. ANOTHER ITEM WAS USED TO COMPLETE THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8947011 ↗

Device details

UDI-DI	`00886385018812`
Brand	STAR
Model	933-0003
Company	Stryker GmbH
Product code	NTG · Prosthesis, Ankle, Uncemented, Non-Constrained
Class	Class 3
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	Apr 14, 2025

Device type (GMDN): Orthopaedic implant aiming arm

A surgical jig-like device designed as a precision guide for the pre-drilling of orthopaedic screw holes into bone and for guiding an orthopaedic instrument into an implanted device, typically to treat long bones (e.g., femur, humerus, and tibia). It typically consists of two parts in one-piece or modular configurations: 1) an insertion guide in which the correctly angled/placed guide holes are situated; and 2) an insertion handle which will attach to the bone or implant. Drill guides or other drilling/tapping devices will be fed through the insertion guide at the precise intended angle, and it may have adaptations for providing magnetic alignment. This is a reusable device.

Other Prosthesis, Ankle, Uncemented, Non-Constrained devices

STAR 400-140F
Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained
27 reports
STAR 400-141F
Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained
24 reports
STAR 400-142F
Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained
23 reports
STAR 400-263
Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained
11 reports
STAR 400-144F
Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained
11 reports
STAR™ 400-143F
Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained
10 reports
STAR 400-254
Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained
7 reports
STAR 400-262
Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained
6 reports

All Prosthesis, Ankle, Uncemented, Non-Constrained 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