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

Catalog Number 283910000

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 04/28/2014

Event Type  malfunction  

Event Description

International affiliate reports that once the cement was mixed, the purple injection device (ie.The confidence kit pump) failed to attach to the full cement container (the kit¿s cement reservoir) through the quick-lock mechanism despite there having been no modification to the integrity of the device by the surgeon or scrub staff.This occurred with two devices from separate confidence kits with the same batch number.When a third kit with a different batch number was opened, there was no problem.The difficulties resulted in a delay of forty five minutes to the procedure.The following mfg.Medwatch reports are being filed for the two confidence kits that were involved in this event: 1526439-2014-11514; 1526439-2014-11515.

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 spinal 11cc cement system was not available for evaluation.A review of the device history records (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 product family as this fault could occur across the entire confidence product line.This analysis found no emerging trends.No corrective action/preventive action (capa) is necessary at this time as we are unable to confirm the reported issue or identify the root cause.Therefore, this complaint file 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.

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 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; 28 chemin blanc; lelocle CH-2 400; SZ CH-2400
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 3815620
• MDR Text Key: 4399046
• Report Number: 1526439-2014-11514
• 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
• Report Date: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 283910000
• Device Lot Number: HRDBG3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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