inforMED
InjuryFFO

MILTEX SELF-RETAINING RETRACTOR

Received Jun 22, 2023 · Event occurred Jun 15, 2023

Report MW5118724 · MDR key 17192193

Device

Generic name

Retractor, Self-retaining

Model number

205-III

Product problems

  • Loose or Intermittent Connection
  • Component Missing

Patient

96 YR · Female

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

AFTER SURGERY FINISHED AND PATIENT OUT OF THE OPERATING ROOM, SCRUB TECH WAS CLEANING UP. ST NOTICED THAT A SCREW WAS LOOSE ON A MILTEX RETRACTOR AND ATTEMPTED TO TIGHTEN SCREW. IN DO SO, THE SCREW AND HINGE PORTION OF THE RETRACTOR FELL OFF. IN INSPECTION OF THE WHOLE MILTEX, THE SCREW-HOLE OF THE HINGE WAS MISSING LESS THAN 1MM PORTION OF METAL. REFER TO ADDITIONAL DOCUMENTS IN I2K¿.