MAUDE Adverse Event Report: NORTHERN DIGITAL, INC. DISPOSABLE REFLECTIVE MARKER SPHERES; REFLECTIVE PASSIVE MARKER SPHERES - HAW, OLO

Model Number 41773K

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2012

Event Type  malfunction  

Event Description

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.

• Brand Name: DISPOSABLE REFLECTIVE MARKER SPHERES
• Type of Device: REFLECTIVE PASSIVE MARKER SPHERES - HAW, OLO
• Manufacturer (Section D): NORTHERN DIGITAL, INC.; waterloo, ontario ; CA
• Manufacturer Contact: gregory gotthelf ; brecha e99 l15e; parque industrial reynosa; reynosa CP887-80 ; MX CP88780 ; 7166916333
• MDR Report Key: 4170678
• MDR Text Key: 4872210
• Report Number: 3002743211-2014-00003
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 41773K
• Device Lot Number: 120222.1
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/21/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2012
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1