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
UnkProduct 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).