MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONFIDENCE HIGH VISCOSITY SPINAL CEMENT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 183901000

Device Problems Fluid/Blood Leak (1250); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2014

Event Type  malfunction  

Event Description

International affiliate reports the confidence cement had been set up and while connecting the confidence hydraulic pump, pressure did not push out the cement.Instead, water from the hydraulic system came out at the connection between the hydraulic pump¿s rectus connector and the confidence cement reservoir cap¿s nipple.As a result, it was not possible to inject the cement into the canula that was being used.A new kit needed to be opened and the surgeon did another procedure during this time so that there was no loss of time because of this incident.Because it is unknown whether the water leakage was attributed to the pump¿s rectus connector or the cement reservoir cap¿s nipple, mfg medwatch reports are being filed for both devices.Confidence cement reservoir & mixer / mfg medwatch report no.1526439-2014-11473.Confidence hydraulic pump / mfg medwatch report no.1526439-2014-11474.

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

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

No visual issues could be found.A device history record for the high visc spinal cement could not be conducted because the lot number is unknown.A 12 month complaint trend analysis for the confidence system was conducted for the cement setting too quickly found no emerging trends.The root cause for the cement setting too quickly cannot be identified because there is no way to determine how long it took the cement to set.No corrective action/preventive action is required as 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.

Event Description

The international affiliate reported that the confidence cement had been set up and while connecting the confidence hydraulic pump, pressure did not push out the cement.Instead, water from the hydraulic system came out at the connection between the hydraulic pump's rectus connector and the confidence cement reservoir cap's nipple.As a result, it was not possible to inject the cement into the canula that was being used.A new kit needed to be opened and the surgeon did another procedure during this time so that there was no loss of time because of this incident.Water leakage has been attributed to the confidence hydraulic pump, filed on mfg.Medwatch report no.1526439-2014-11474.The confidence cement reservoir and mixer involved in the complaint is a concomitant device.This mfg.Medwatch report 1526439-2014-11473 was corrected on follow up report #1 to be for confidence high viscosity spinal cement, 182901000, which had set up while connecting the confidence hydraulic pump.

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 HIGH VISCOSITY SPINAL CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): TEKNIMED SAS; 38 chemin blanc; vic en bigorre 6550 0; FR 65500
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 3770972
• MDR Text Key: 21525966
• Report Number: 1526439-2014-11473
• 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,Followup,Followup
• Report Date: 04/01/2014

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: 183901000
• Device Lot Number: HPNBBR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 04/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/03/2014; 06/10/2014; 06/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2013
• 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
• Treatment: CANULA, CATALOG NO. UNKNOWN; CONFIDENCE CEMENT, (B)(4)
• Patient Age: 78 YR