inforMED
MalfunctionHAW

DISPOSABLE REFLECTIVE MARKER SPHERES

Received Jul 11, 2014 · Event occurred Dec 8, 2012

Report 3002743211-2014-00003 · MDR key 4170678

Device

Generic name

Reflective Passive Marker Spheres - Haw, Olo

Model number

41773K

Lot number

120222.1

Product problems

  • Device Misassembled During Manufacturing /Shipping

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

WHEN SCREWING ON A SPHERE TO AN INSTRUMENT, THE SPHERE FELL APART. THIS ISSUE OCCURRED AT THE START OF A PROCEDURE. CUSTOMER RETURNED AFFECTED PRODUCT FOR EVALUATION. INVESTIGATION OF THIS ISSUE DETERMINED THAT NO ADHESIVE WAS APPLIED TO THE TWO HEMISPHERES OF THE SPHERE. DURING ASSEMBLY OF THE SPHERE, THE ADHESIVE IS DISPENSED MANUAL, THEREFORE THIS IS AN ISOLATED CASE OF OPERATOR ERROR. THIS FAILURE HAS NOT RECURRED SINCE THIS REPORT. NO SERIOUS IMPLICATIONS TO THIS ISSUE WERE MENTIONED BY THE COMPLAINANT. NO PT WAS HARMED AND NO SERIOUS INJURY OCCURRED.