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

Catalog Number 07.704.005S

Device Problem Leak/Splash (1354)

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

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

Patient id: (b)(6).Patient weight is unknown (b)(4).Device was not implanted/explanted.Device history record review part number: 07.704.005s, lot number: dsc2468: release to warehouse date: november 5, 2014.Expiration date: july 28, 2016.Manufacturing site is synthes (b)(4) and supplied by (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Event Description

It was reported that a male patient sustained a fracture of the left tibial plateau and underwent an open reduction internal fixation on (b)(6) 2015.During the mixing process of norian boney void filler, the tip of the syringe containing sodium hyaluronate solution leaked.This event occurred outside of the sterile field.Another material was available for use.There was no surgical delay.It was reported that the procedure was successfully completed and that the patient outcome was fine.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A manufacturing evaluation was completed: the shipping box was noted to be heavily damaged.The empty solution syringe was returned and examined.The syringe, luer lock tip and cap were separated when returned.Inside the pouch, some partially hardened norian powder proximal to the solution inlet port material was observed.The sodium hyaluronate syringe was empty.No visible damage could be detected on any syringe components, the syringe, luer lock tip or cap.When re-assembled with the luer lock connection and filled with water, the solution showed no signs of leakage.The syringe could also be successfully attached and water injected without leakage into inlet port of the rotary pouch.Review of all manufacturing and inspection records indicates no process or inspection deviations or non-conformances related to the product failure.The root cause of the leak was most likely an incomplete connection between then luer lock tip component and solution syringe.No manufacturing related issue was identified and/or confirmed.No conclusive root cause can be assigned for the disconnection of the luer lock tip form the 5cc solution syringe.However, the root cause of the leak was determined to most likely be an incomplete connection between then luer lock tip component and solution syringe.No manufacturing related issue was identified and/or confirmed.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 PREFOR MED 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: 5334989
• MDR Text Key: 34755884
• Report Number: 1719045-2015-10861
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2016
• Device Catalogue Number: 07.704.005S
• Device Lot Number: DSC2468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR