V. Mueller OS4080-002Recalls & reported problems

Steris Corporation · BONE HOOK BLUNT, HEAVY MODEL HOOK DIAMETER 3/4 inches1.9CM OVERALL LENGTH 9 inches22.9CM · Class 1

All models of V. Mueller (118)

Data updated Oct 16, 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 10885403103360), received between Dec 28, 2021 and Dec 28, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Break1

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.

MalfunctionDec 28, 2021Break; Break
AN OS4080-002 DEVICE BROKE DURING A LEFT SHOULDER REVERSE TOTAL ARTHROPLASTY OPERATION. A PIECE OF DEVICE FELL INTO THE PATIENT AND COULD NOT BE REMOVED WITHOUT CAUSING FURTHER HARM TO THE PATIENT. HOWEVER, THE OPERATION WAS COMPLETED AS PLANNED AND THE PATIENT WAS DISCHARGED TO THEIR HOME. NO FURTHER INJURY OR HARM HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13097391 ↗

Device details

UDI-DI	`10885403103360`
Brand	V. Mueller
Model	OS4080-002
Catalog no.	OS4080002
Company	Steris Corporation
Product code	KIK · HOOK, BONE
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 23, 2024

Device type (GMDN): Bone hook

A hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. This is a reusable device.

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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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