MalfunctionGAD

METRX® SYSTEM 18MM DISPOSABLE RETRACTOR

Received May 22, 2025 · Event occurred May 2, 2025

Report 22069609 · MDR key 22069609

Device

Generic name

Retractor

Manufacturer

Medtronic Sofamor Danek Usa, Inc.

Product problems

Break
Material Fragmentation
Retraction Problem

Patient

62 YR · Female

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

METRX DISPOSABLE ANGLED TUBULAR RETRACTOR (18MM X 6CM) BROKE DURING SURGERY WHILE IN THE SURGICAL SITE. RETRACTOR IS A CIRCULAR POLYMER TUBE, AND IS NOT X-RAY DETECTABLE. METHODICAL SURGICAL SITE EXAMINATION WAS COMPLETED AND FRAGMENTS COLLECTED AND PASSED OFF THE STERILE FIELD.