MalfunctionISH

MULTIFLEX ANKLE BALL & STEM ASSEMBLY

Received Aug 6, 1997 · Event occurred Apr 20, 1997

Report 1058311-1997-00002 · MDR key 111687

Device

Generic name

Prosthetic Ankle Component

Manufacturer

Chas. A. Blatchford, Ltd.

Model number

409316

Catalog number

409316

Lot number

Product problems

Component(s), broken
Installation error
Misassembled

Patient

51 YR

Narrative

Description of Event or Problem

THREADED AREA OF BALL AND STEM ASSEMBLY BROKE IN HALF, CAUSING SEATTLE LIGHT FOOT TO FALL OFF. PT DID FALL AND WAS ABLE TO BREAK FALL, RESULTING IN NO INJURY.