DISPOSABLE REFLECTIVE MARKER SPHERES
Received Oct 8, 2015 · Event occurred Apr 8, 2015
Report 3002743211-2015-00056 · MDR key 5134612
Device
Generic name
Reflective Passive Marker Spheres
Manufacturer
Northern Digital Inc.Model number
41773Lot number
C101021502
Product problems
- Material Separation
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS FAILURE MODE HAS BEEN IDENTIFIED PREVIOUSLY AND CORRECTIVE ACTIONS HAVE BEEN TAKEN. THE SPHERE SEPARATED INTO TWO HEMISPHERES DUE TO INADEQUATE ADHESIVE APPLIED TO THE SPHERE DURING PRODUCTION. THE ROOT CAUSE FOR THIS FAILURE WAS IDENTIFIED AS A MANUFACTURING DEFICIENCY. CORRECTIVE ACTIONS HAVE ALREADY BEEN IMPLEMENTED AND INCLUDE: 1. ADJUSTMENTS TO THE MANUFACTURING PROCESS OF THE SPHERE TO ENSURE ADEQUATE CURING OF ADHESIVE. 2. A NOTICE SENT TO AFFECTED CUSTOMERS ADVISING OF A FIELD CORRECTION FOR OTHER LOTS MANUFACTURED PRIOR TO ANY CORRECTIVE ACTIONS. 3. A 100% IN-PROCESS INSPECTION STEP TO DETECT THE FAILURE MODE. DEVICE NOT RETURNED.
Description of Event or Problem
CUSTOMER ADVISED THAT A DISPOSABLE REFLECTIVE MARKER SPHERE (LOT C101021502) SEPARATED INTO TWO HEMISPHERES. THIS OCCURRED INTRAOPERATIVE AT (B)(6) HOSPITAL, UPON AFFIXING THE SPHERE ONTO A TOOL. CUSTOMER ALSO MENTIONED THAT A SIMILAR INCIDENT OCCURED TWO MONTHS PRIOR TO THIS INCIDENT, HOWEVER NO LOT INFORMATION, NO PICTURES OR SAMPLES WERE PROVIDED FOR THE SECOND OCCURENCE. CUSTOMER REPORTED NO SERIOUS INJURY/DEATH TO PATIENT OR USERS. CUSTOMER REPORTED NO NEGATIVE EFFECT TO PATIENT DUE TO THIS ISSUE.