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

Catalog Number 283910000

Device Problem Connection Problem (2900)

Patient Problem No Code Available (3191)

Event Date 11/28/2013

Event Type  Injury  

Event Description

It was reported that the connection between the hydrolic pump system and cement system could not be established prior to the procedure.At least 2 hours delay occurred where the cement hardened, rendering it unusable.Another of the same product was used to complete the procedure.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

Visual inspection of the returned noted that the glass reservoir is filled with dried cement.The hydraulic pump was able to be connected to the reservoir with no issues.A review of the device history record for the confidence kit found no discrepancies during the manufacturing of the product.No issues were identified during the manufacturing and release of this product that could have been contributed to the problem reported by the customer.The product was released accompanying all quality requirements.A 12 month complaint trend analysis was performed on the confidence spinal cmt sys, 11c on the confidence family, as this failure mode could present itself across any device.There was no harm to the patient reported in this complaint but potential harm may exist if the fault were to recur.Review of complaints found no significant trends.The root cause for the pump not being able to connect to the reservoir cannot be determined because the issue could not be confirmed.No corrective action/preventive action is required as there has been no issue identified in the manufacturing or release of this device, and there have been no systematic trends.Therefore, this complaint will be closed with no further action required.

• Brand Name: CONFIDENCE SPINAL CMT SYS, 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: 3561190
• MDR Text Key: 19567261
• Report Number: 1526439-2014-10316
• 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: 12/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 283910000
• Device Lot Number: HPLB2M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2013
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/28/2013
• Event Location: Hospital
• Date Manufacturer Received: 12/06/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2013
• 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
• Patient Outcome(s): Other