InjuryKIK

V.MUELLER BONE HOOK

Received Dec 16, 2021 · Event occurred Dec 14, 2021

Report MW5106136 · MDR key 13026022

Device

Generic name

Hook, Bone

Manufacturer

V.mueller / Carefusion 2200, Inc.

Model number

A01-0S4080-002

Product problems

Entrapment of Device
Material Separation

Patient

69 YR · Male

Device Embedded In Tissue or Plaque
Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

BONE HOOK BROKE DURING TRIAL IMPLANT PORTION OF SURGERY AND DECISION WAS MADE BY SURGEON TO INTENTIONALLY LEAVE PIECE BEHIND TO PREVENT FURTHER DAMAGE. FDA SAFETY REPORT ID #:(B)(4).