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

Catalog Number 283910000

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2014

Event Type  malfunction  

Event Description

International affiliate reports that during a vertebroplasty procedure, the container with cement was disconnecting from its lid.The cement has been tensed (hardened).The same type product was used to complete the procedure.The affiliate has not provided requested information regarding clarification of the event.It appears that the cement hardening was due to difficulty with the container disconnecting from the lid.Also, the affiliate is not able to confirm that the resulting delay was less than thirty minutes at this time.Due to the lack of information provided, this complaint is being submitted as a reportable malfunction involving the confidence spinal cement system.

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

Visual examination of the returned confidence kit found cement was outside of the threaded portion that the cement reservoir attaches too.Review of the device history record for the confidence kit found the lot met specification requirements when released to stock.Also, review of the device history record for the concomitant device cement found no discrepancies.A 12 month complaint trend analysis for the confidence product family found no complaints related to difficulty transferring cement to the cement reservoir because of a connection issue.The root cause for the cement reservoir coming off of the transfer adapter cannot be positively identified.However, it may have been due to the shipping and handling of the transfer adapter and vial prior to use.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 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.

• 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: 3888749
• MDR Text Key: 4653412
• Report Number: 1526439-2014-11618
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 283910000
• Device Lot Number: HRBBN7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2014
• 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: CONFIDENCE CEMENT