MAUDE Adverse Event Report: SYNTHES MONUMENT NORIAN DRILLABLE INJECT 5CC-STERILE; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Catalog Number 07.704.005S

Device Problems Clumping in Device or Device Ingredient (1095); Filling Problem (1233)

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

Event Date 05/07/2015

Event Type  malfunction  

Event Description

It was reported that after following the preparation instructions, the norian injectable cement would not mix and almost none of it could be dispensed into the syringe during a surgical procedure on (b)(6) 2015.This mixture was not usable.Another norian mix was readily available and performed as expected.There was no surgical delay and there was no harm to the patient.The surgery was successfully completed.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information was not provided by reporter.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A manufacturing evaluation was completed: the norian drillable inject rotary pouch was returned.The components appear to be intact.It was noted nixed (now hardened product) was extruded.The pouch was cut open and very little material, mixed or otherwise was present within the pouch.It is unknown how much of the product was extruded.The bulk of remaining product was hydrated with solution and remained at the top portion near the ejection port, indicating that mixed material was extruded and flowed as intended.The devices were inspected to the prescribed pre-determined acceptance criteria.There were no non-conformances noted.The product met all pre-determined acceptance criteria.It is apparent that most of the product was extruded, however, the condition of the product at the time of extraction cannot be known.No conclusive root cause can be assigned.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: NORIAN DRILLABLE INJECT 5CC-STERILE
• Type of Device: FILLER, CALCIUM SULFATE PREFORMED PELLETS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4811452
• MDR Text Key: 5830669
• Report Number: 1719045-2015-10338
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK102722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Catalogue Number: 07.704.005S
• Device Lot Number: DSC1747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2014
• 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