NA 03.306.008Recalls & reported problems

Synthes GmbH · THREADED TUBE FOR PELVIC C-CLAMP II · Class 2

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 10886982077714), received between Jan 3, 2025 and Jan 3, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device-Device Incompatibility1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionJan 3, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED ON AN UNKNOWN DATE IN 2024, THE BOLT IS STRIPPED IN THE LOWER ARM OF THE CLAMP. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21067936 ↗

Device details

UDI-DI	`10886982077714`
Brand	NA
Model	03.306.008
Catalog no.	03306008
Company	Synthes GmbH
Product code	JEC · COMPONENT, TRACTION, INVASIVE
Class	Class 2
FDA submission	K071476
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 28, 2022

Device type (GMDN): Pelvic C-clamp

A manual surgical instrument designed as an emergency stabilization device for unstable injuries and fractures of the pelvic ring; these conditions can be associated with massive blood loss and terminal shock. It is mechanically fixed to either side of the pelvis by means of thick nails permitting quick and efficient compression and stabilization of pelvic fractures and luxations providing time for haemorrhage and embolization control. It is typically designed as a C-shaped frame with a rail, twin adjustable arms, adjusting side screws, and nails made of high-grade stainless steel and/or synthetic material. It is compatible for use in computed tomography (CT). This is a reusable device.

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All COMPONENT, TRACTION, INVASIVE 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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