MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONFIDENCE KIT, NO NEEDLES; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 283913000

Device Problems Leak/Splash (1354); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2014

Event Type  malfunction  

Event Description

International affiliate reports that during the procedure, the cement was well mixed.When the quick connector valve from the confidence kit¿s pump was attached to the cement reservoir and cement was injected, the pump started to disconnect from the attachment and cement was not injected.Water is reported to have leaked from the pump at the connection of the quick connect assembly to the cement reservoir.Also, cement is reported to have hardened during injection after eight minutes.Another kit was available for use.There were no adverse consequences to the patient and no significant delay to the procedure.The following mfg.Medwatch reports are being filed for the confidence kit and high viscosity spinal cement that were involved in the event: 1526439-2014-11529, 1526439-2014-11530.

Manufacturer Narrative

A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The confidence kit, no needles was returned for evaluation.A performance evaluation found no issues with the device.A review of the device history record (dhr) identified no issues during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A 12 month review of the complaint trend analysis for the confidence kit was conducted on the family as this failure mode could occur on the entire confidence product line.This analysis found no emerging trends.The root cause for the pump leaking at the connection to the reservoir cannot be positively identified.However, it may have been due to the connection not being fully engaged.No corrective action/preventive action is required at this point as there has been no issues identified in the manufacturing or release of this device, and there have been no systematic trend.Therefore, this complaint will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONFIDENCE KIT, NO NEEDLES
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 38 chemin blanc; lelocle CH-2 400; SZ CH-2400
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 3838751
• MDR Text Key: 4454609
• Report Number: 1526439-2014-11529
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 283913000
• Device Lot Number: HPLBC9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 05/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2013
• 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