inforMED
InjuryGDR

GIGLI SW

Received Aug 19, 2020 · Event occurred Aug 11, 2020

Report MW5096157 · MDR key 10431300

Device

Generic name

Saw, Manual And Accessories

Manufacturer

Unk

Product problems

  • Detachment of Device or Device Component

Patient

71 YR

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

WHILE THE SURGEON WAS ATTEMPTING TO REMOVE THE FEMORAL COMPONENT OF THE TOTAL HIP, WIRES OF THE GIGLI SAW SNAPPED, AND WERE IMMEDIATELY ACCOUNTED FOR. NO PATIENT HARM. PROCEDURE COMPLETED WITHOUT ISSUE. NO IMAGING NECESSARY. PER SURGEON: GIGLI SAWS ARE DESIGNED TO SNAP WHEN THE FRICTION AGAINST THEM IS TOO HIGH. IT'S A SAFETY MECHANISM. THERE WAS NOT ANY PATIENT HARM, AND THERE WAS NO RETAINED MATERIAL IN THE PATIENT. FDA SAFETY REPORT ID# (B)(4).