MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONFIDENCE KIT, NO NEEDLES; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 283913000

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2014

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that the confidence system "tensed" before the physician was able to use the device.It is likely that the cement set time was earlier than anticipated.The procedure was completed with another of the same product with a delay of no more than 20 minutes to completion.

Manufacturer Narrative

One confidence kit, no needles was returned for evaluation.Only the pump was returned.There is nothing visually wrong with the pump, and no testing was done on it because the complaint is complaining about the cement solidifying too quickly.A review of the device history record for the confidence kit, no needles 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 cement setting too quickly was conducted on the entire confidence family, as this failure mode can present itself across the entire family.Is this complaint, there was no harm to the patient however the potential for harm exists if this fault were to recur.Review of complaints found no significant trends.The root cause for the cement setting too quickly cannot be positively identified.However, the cement may have set too quickly due to the environment where it was stored or during the surgery.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 KIT, NO NEEDLES
• 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: 3619317
• MDR Text Key: 19456939
• Report Number: 1526439-2014-11239
• 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
• Type of Report: Initial,Followup
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 283913000
• Device Lot Number: HPLBFK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/16/2014
• Event Location: Hospital
• Date Manufacturer Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1