NA 03.605.515Recalls & reported problems

Synthes GmbH · PITUITARY RONGEUR-CURVED 6MM WIDTH · Class 1

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 10705034712598), received between Apr 29, 2024 and Apr 29, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

Reports received per month

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

Most reported problems

Device problems

Contamination /Decontamination Problem1
Material Integrity Problem1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionApr 29, 2024Contamination /Decontamination Problem; Material Integrity Problem; Contamination /Decontamination Problem; Material Integrity Problem
IT WAS REPORTED ON APRIL 4 2024, THE RONG CURVE WAS GLITCHING AND WAS THEREFORE DEFECTIVE. AFTER DISASSEMBLY THERE WAS ALSO CONTAMINATION FOUND. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE RONG CURV 6 BLACK THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 19201055 ↗

Device details

UDI-DI	`10705034712598`
Brand	NA
Model	03.605.515
Catalog no.	03605515
Company	Synthes GmbH
Product code	HTD · FORCEPS
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	Apr 26, 2022

Device type (GMDN): Orthopaedic joint/limb rongeur

A hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.

Other FORCEPS devices

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AESCULAP BJ043R
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AESCULAP MD569
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ATRAUMATA FB483R
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AESCULAP BJ045R
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1 recall0 reports

All FORCEPS 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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