MalfunctionHTY
ZIMMER BIOMET STERILE WIRE PIN
Received Jun 11, 2021 · Event occurred May 25, 2021
Report MW5101860 · MDR key 11991636
Device
Generic name
Pin, Fixation, Smooth
Manufacturer
Zimmer IncProduct problems
- Break
- Entrapment of Device
Patient
76 YR
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
STERILE PINS WERE PLACED TO HOLD A CUTTING GUIDE IN PLACE WHILE USING A SAW. AFTER CUTTING GUIDE WAS USED PINS WERE REMOVED BUT A PIECE OF THE STERILE PIN HAD BROKE OFF AND REMAINED EMBEDDED IN THE BONE. ZIMMER WIRE PIN START (B)(6) 2021, END DATE (B)(6) 2021. FDA SAFETY REPORT ID # (B)(4).