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

Catalog Number 283913000

Device Problems Decrease in Pressure (1490); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2014

Event Type  malfunction  

Event Description

International affiliate reports that on opening two confidence kit boxes, it appeared that pressure was lost prematurely during cement application and the surgeon was unable to inject the cement or the confidence kits¿ cement had hardened before it could be injected.The difficulty did not result in any delay to the procedure and it is reported that patient was not affected.Additional kits were available to complete the procedure.The following mfg.Medwatch reports are being filed for the two confidence kits that were involved in this event.1526439-2014-11842; 1526439-2014-11843.

Manufacturer Narrative

The confidence kit and its components were not returned for evaluation.Device history record review for the confidence kit and its component pump found no discrepancies.Review of the device history record for its component cement found one unrelated nonconformance.Complaint trend analyses for the kit, pump, and cement found no emerging trends.The root cause for the lost pressure or cement hardening prior to injection cannot be positively determined.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 its components and there has 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.

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

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; chemin blanc 38; le locle CH-2 400; SZ CH-2400
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 4043888
• MDR Text Key: 4859288
• Report Number: 1526439-2014-11842
• 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,Followup
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 283913000
• Device Lot Number: HPKBLD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2013
• 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