inforMED
MalfunctionHTO

XMCP

Received Dec 13, 2018 · Event occurred Nov 7, 2018

Report 3007289093-2018-00033 · MDR key 8161956

Device

Generic name

Reamer

Catalog number

120-01000

Lot number

3327501

Product problems

  • Fracture
  • Fracture

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DURING A SURGICAL PROCEDURE, THE XMCP REAMER BEGAN TO TWIST AND BREAK AT THE DISTAL TIP.