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

Catalog Number 283913000

Device Problem Decrease in Pressure (1490)

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

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

During cement augmentation of the screws pressure of the hydraulic system fell and the surgeons was not able to operate the system, a new package of confidence was needed to continue surgery.

Manufacturer Narrative

(b)(4).The needleless confidence kit (product code: 2839-13-000, lot number: 103634) was not returned to the customer quality unit (cqu).While it was initially identified that the shaft was available, the response to the first return request stated that the product could not be sterilized and thus would not be returned.No sample is expected to be returned at this time.The status of the sample has been updated to ¿none.¿ the returned images are not sufficient to determine the functionality of the pump.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.Without the return of the device in question we are unable to confirm the reported issue or identify the root cause.If the device is returned at a later date, the complaint will be reopened and the sample will be evaluated.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, 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.Sample not returned.

• Brand Name: CONFIDENCE KIT, NO NEEDLES
• Type of Device: CONFIDENCE CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6501214
• MDR Text Key: 73101243
• Report Number: 1526439-2017-10262
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 283913000
• Device Lot Number: 103634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2016
• 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