MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NORIAN DRILLABLE FAST SET PUTTY 10CC-STERILE; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Model Number	07.704.110S
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: patient information not available for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 or Problem Description
It was reported that two (2) norian drillable fast set putty solidified too quickly while using the delivery system to deliver the biomaterial during a procedure on (b)(6) 2018.The surgical team was not able to get it out of the syringe as it became clogged or blocked.The issue happened twice.The product was replaced with norian drillable inject to complete the procedure.It is unknown if there was a surgical delay related to the incident reported.There was no patient consequence.Concomitant devices reported: graft delivery device (part 03.950.001s, lot number unknown, quantity 2).This report is for one (1) norian drillable fast set putty 10cc.This is report 1 of 2 for (b)(4).

• Brand Name: NORIAN DRILLABLE FAST SET PUTTY 10CC-STERILE
• Common Device Name: FILLER, CALCIUM SULFATE PREFORMED PELLETS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7747151
• Report Number: 2939274-2018-53175
• Device Sequence Number: 13879545
• Product Code: MQV
• UDI-Device Identifier: 10886982131652
• UDI-Public: (01)10886982131652
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 07.704.110S
• Device Catalogue Number: 07.704.110S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/03/2018
• Patient Sequence Number: 1