MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONFIDENCE SPINAL CEMENT SYSTEM, 11C; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 283910000

Device Problems Loose or Intermittent Connection (1371); No Flow (2991)

Patient Problem No Information (3190)

Event Date 03/22/2014

Event Type  malfunction  

Event Description

International affiliate reports the confidence kit presented a problem during the procedure.Reports the applicator of cement (which is attached to the needle) was loose plunger.While placing the cement, the plunger (black end) closed the output of cement, preventing the use.Three requests have been made to the affiliate for additional information and clarification.To date, the requested information has not been provided.It is not known if another kit was available to complete the procedure without any adverse consequences to the patient or if the difficulty resulted in a significant delay to the procedure.As a result of the lack of information that has been provided, a medwatch report is being submitted to document this event.

Manufacturer Narrative

Additional 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 11cc spinal cement system was not returned for evaluation.However, based on the complaint what most likely happened was that the surgeon connected the cap to the reservoir before transferring cement, which would cause the plunger to be in the empty cement reservoir.This would prevent the reservoir from being loaded correctly and a new set would have to be used in order to correctly apply cement.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 system was conducted on the family.This analysis found no emerging trends.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.Not returned for evaluation.

• Brand Name: CONFIDENCE SPINAL CEMENT SYSTEM, 11C
• 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: 3863813
• MDR Text Key: 4567964
• Report Number: 1526439-2014-11605
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2014

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: 283910000
• Device Lot Number: HPJBLM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 06/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2013
• 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