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

Catalog Number 283910000

Device Problems Filling Problem (1233); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2014

Event Type  malfunction  

Event Description

International affiliate reports two confidence kit needles were inserted into the spine.The cement mixture was injected into the spine via the first needle.When the surgeon tried to inject the remaining cement into the second needle, water was leaking from the confidence kit¿s hydraulic pump and the cement could not be pushed from the kit¿s cement reservoir into the vertebra.Reports it was 2-3 minutes later than the mixture was done.Another kit was opened, new cement was mixed, and the procedure was successfully completed.The procedure as extended by ten minutes and, as reported, the patient was not in any danger.

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

One confidence spinal cmt sys, 11c [product code: 2839-10-000, lot no: hpncg8] was returned for evaluation.The pump was tested with a pressure gage to ensure output of the correct pressure.The pumped maxed at 173.8 bar before the safety valve engaged.This is within the specification of 151.5-188.5 bar according to the manufacturing process specification, mps-hpc006 rev u.A review of the device history record for the confidence spinal cmt sys, 11c 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 for the confidence spinal cmt sys, 11c was conducted on the entire confidence family, as cement setting too quickly is not unique to this product code.In this complaint there was no harm to the patient nor would harm be expected if this fault were to recur.Review of complaints found no significant trends.The root cause for water leaking out of the pump can be attributed to the cement setting too quickly.The root cause for the cement setting too quickly cannot be positively identified.However, it may be due to the environment of the storage location or use of the cement.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: 3663707
• MDR Text Key: 4343874
• Report Number: 1526439-2014-11338
• 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: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 283910000
• Device Lot Number: HPNCG8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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