NA 02.207.080Recalls & reported problems

Synthes GmbH · 7.3MM CANNULATED LOCKING SCREW 80MM · Class 2 · Implant

Data updated Oct 16, 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 10886982051851), received between Sep 20, 2021 and Sep 20, 2021 — classified as 1 injury.

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

Adverse Event Without Identified Device or Use Problem1

Patient problems

Nonunion/Delayed-union Bone Fracture1

Recent adverse event reports

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

InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A REMOVAL PROCEDURE, THE PLATE WAS REMOVED DUE TO BONE HEALING FAILURE. THIS WAS IMPLANTED NO (B)(6) 2021. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 7.3MM CANNULATED LOCKING SCREW 80MM. THIS REPORT IS 1 OF 10 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 12502157 ↗

Device details

UDI-DI	`10886982051851`
Brand	NA
Model	02.207.080
Catalog no.	02207080
Company	Synthes GmbH
Product code	HTY · PIN, FIXATION, SMOOTH
Class	Class 2
FDA submission	K000066
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 6, 2025

Device type (GMDN): Orthopaedic bone screw (non-sliding)

A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

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All PIN, FIXATION, SMOOTH 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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