MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONFIDENCE KIT SPINAL CEMENT SYSTEM - NO NEEDLE; CONFIDENCE CEMENT, BONE, VERTEBROPLASTY

Catalog Number 283913000

Device Problem Leak/Splash (1354)

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

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Confidence complaint per complaint form: during a 1 level vertebral body augmentation procedure, the surgeon began the step of implanting cement using the confidence system.The devices were assembled on the back table and handed to the surgeon.He attached the glass vial of cement to the delivery cannula and began turning the hydraulic pump that injects the cement into the patient.Surgeon observed that hydraulic fluid appeared to be leaking at the attachment point of pump to glass vial.He stopped and tightened the connection.He tried again and there was increased pressure and then a subsequent leaking of fluid under pressure.A stream of fluid shot out at 90 degrees from the insertion cannula and extended for 4-5 feet.At that point, surgeon removed the pump, cement, and insertion cannula assembly from the patient.Another confidence kit was opened, and a new batch of cement was mixed with a new pump and glass container.Surgeon then proceeded with this new equipment and the surgery continued as planned.There was no harm to the patient other than a 2-3 minute delay while getting a new kit opened and new cement prepared.

• Brand Name: CONFIDENCE KIT SPINAL CEMENT SYSTEM - NO NEEDLE
• Type of Device: CONFIDENCE CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6213641
• MDR Text Key: 63629430
• Report Number: 1526439-2016-10955
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 283913000
• Device Lot Number: HVKBCY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 61 YR