MAUDE Adverse Event Report: DFINE INC. MULTIPLEX CONROLLER; MULTIPLEX CONTROLLER

Catalog Number 3610

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190); No Code Available (3191)

Event Date 07/16/2015

Event Type  malfunction  

Manufacturer Narrative

The product has not been received within our facility for evaluation.Upon receipt, final evaluation will be conducted and supplemental report will be filed accordingly.

Event Description

Per received report: during 3 level va case t6, 8 and 9, and while delivering cement to the last level, the multiplex controller stopped showed cement delivery on screen.On flouro, the cement was not seen exiting the delivery cannula (dc) which was in the middle 1/3 of the vertebral body.The territory sales manager (tsm) immediately looked for resistance bars on the multiplex which would demonstrate that the situation could have been up against a hard bone and resistance sensed.The physician was asked to stop delivery, which he already did.The cannula was then pulled back a few millimeters and attempted delivery.Same thing occurred with no bars present, and the physician hit stop.He pulled back a few millimeters and a significant amount of cement entered the vertebral body from dc, shot backwards very quickly and appeared to enter the spinal canal.Patient was asymptomatic for any neuro deficit post op.The cement syringe was examined and noted less than 1 cc remaining.The equipment failed to notify the user via resistance bas that there was na issue with normal delivery of cement.Is also failed to notify user that 1 cc was remaining via resistance bar build and audible tone change.No patient injury reported.

Manufacturer Narrative

The customer reported issue could not be confirmed.Upon inspection on the multiplex controller performed in-house, all visual, electrical and functional testing passed and all required specifications were met.There were no noted issues, red light flashing, awkward beep, graphic display or any significant failure was noted during the testing process that would indicate any discrepancies as indicated in the initial report.The additional testing performed via activation element (ae) tip occlusion revealed that the unit did not fail to alert user as it encountered dense material by the emergence of resistance bars on the front display of the unit combined with an audible tone.In addition, a change in the audible tone as the unit reached <1cc remaining in the syringe was heard, contrary to the initial report that equipment failed significantly.Furthermore, the emergence of the resistance bars on the screen and the change in the audible tone as the cement decreased to <1cc remaining may not have been observed or heard by the user during the procedure.Hence these safety features were achieved as designed.The unit performed as intended and is functionally fit for use.Although there does not appear to be any indication of a product quality deficiency, a definitive cause for the reported issue cannot be determined.All units are 100% visually inspected and tested for its functionality during the manufacturing process and only passing units are moved to the next process.Additionally, the unit undergoes through series of electrical evaluations to verify the multiplex controller's integrity.

• Brand Name: MULTIPLEX CONROLLER
• Type of Device: MULTIPLEX CONTROLLER
• Manufacturer (Section D): DFINE INC.; 3047 orchard parkway; san jose CA 95134
• Manufacturer Contact: dan balbierz ; 3047 orchard parkway; san jose, CA 95134-0000
• MDR Report Key: 5008470
• MDR Text Key: 24715231
• Report Number: 3006396387-2015-00011
• Device Sequence Number: 1
• Product Code: GFI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3610
• Device Lot Number: DMC-500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2013
• 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