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

Catalog Number 283910000

Device Problems Filling Problem (1233); No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Date 03/26/2014

Event Type  malfunction  

Event Description

It was reported that as the technician went to remove the t-handle from the mixing resevior, the cement had hardened so that the t-handle could not be removed, and thus the glass resevior could not be inserted to collect the cement.The physician suspects premature setting of the cement or difficulty with teh t-handle collar resulting in a delay to cause cement hardening, as the technician was very familiar with teh process.There was no patient involvement.

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

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was not returned, therefore an evaluation could not be performed.A dhr (device history record) review was performed for the confidence kit 283910000 lot: hpnbb4, and no discrepancies were observed during the manufacturing and release of this product that could have contributed to the problem reported by the customer.As such, these devices were released accomplishing all quality requirements.A 12 month complaint trend analysis for the confidence spinal cmt sys, 11c was conducted for the entire family.No systemic trends were identified.The root cause for the cement setting too quickly cannot be positively identified.However, it may have been due to the environment the cement was stored or mixed in.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 have been no systematic trend.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: 3757177
• MDR Text Key: 4467008
• Report Number: 1526439-2014-11464
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 283910000
• Device Lot Number: HPNBB4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/26/2014
• Event Location: Hospital
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1