NA MWA301Recalls & reported problems

Tornier · Bone Graft Pliers · Class 1

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700386968297), received between Oct 3, 2023 and Oct 15, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

Break2
Fracture2
Detachment of Device or Device Component1

Patient problems

No Clinical Signs, Symptoms or Conditions3
Foreign Body In Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 15, 2024Break; Fracture; Break; Fracture
DURING SURGERY, THE PLIERS IN QUESTION WERE DAMAGED IN THE PLASTIC PART.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 20450124 ↗
MalfunctionMar 4, 2024Break; Fracture; Break; Fracture
AS REPORTED: "GRAFT PLUNGER BROKEN".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18828449 ↗
MalfunctionOct 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED: "SCREW FELL OUT AND INNER PART WAS LOOSE IN THE BOX".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17862262 ↗

Device details

UDI-DI	`03700386968297`
Brand	NA
Model	MWA301
Company	Tornier
Product code	HXD · CLAMP
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	Aug 16, 2022

Device type (GMDN): Bone approximation clamp

A hand-held manual surgical instrument designed to grip and hold a bone or, being used in pairs one on either side of the fracture, to approximate the proximal and distal segment of a fractured bone during orthopaedic surgery. It is typically made of high-grade stainless steel and is designed with a double hooked, blade-like jaw at the distal end (this hooks over the upper edge of the bone) whilst an adjustable single hook is tightened against the lower edge of the bone through a screw mechanism. A traction bar may be employed to bridge the two bone clamps and using its screw mechanism, the fracture is drawn together. This is a reusable device.

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All CLAMP devices →

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