DynaClip Quattro 3000-11-221616Recalls & reported problems

Medshape, Inc. · QUATTRO DYNACLIP STAPLE, 22X16X16 · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M9703000112216160), received between Aug 26, 2024 and Aug 26, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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

Deformation Due to Compressive Stress1
Material Integrity Problem1

Patient problems

Failure of Implant1
Implant Pain1

Recent adverse event reports

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

InjuryAug 26, 2024Deformation Due to Compressive Stress; Material Integrity Problem; Deformation Due to Compressive Stress; Material Integrity Problem
IT WAS REPORTED THAT THE STAPLE WAS PUT OVER AN EVANS TITANIUM WEDGE TO KEEP IN PLACE AND THE LEGS ENDED UP BREAKING ON THE STAPLE CAUSING PAIN.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 20072568 ↗

Device details

UDI-DI	`M9703000112216160`
Brand	DynaClip Quattro
Model	3000-11-221616
Company	Medshape, Inc.
Product code	JDR · Staple, Fixation, Bone
Class	Class 2
FDA submission	K220812
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Aug 20, 2025

Device type (GMDN): Orthopaedic bone staple, non-adjustable

A non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.

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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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