MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NORIAN DRILLABLE INJECT 3CC-STERILE; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Model Number	07.704.003S
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4); release to warehouse date: january 04, 2018; expiration date: august 28, 2019; part: 07.704.003s, lot: dse6933 (sterile) - norian drillable inject 3cc ¿ sterile; lot quantity:155.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of conformance received from dsm dated december 27, 2017 was found to be conforming.Sterility requirements on certificate were found to be conforming.No nonconformance reports (ncrs) were generated during the inspection or release of this lot.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 during an open reduction internal fixation (orif) of femoral head fracture on (b)(6) 2018, nothing came out into the patient from the norian drillable inject when it was rolled through the roller after mixing for 70 revolutions.The product was within the expiration date; the temperature indicator was adequate; and the appropriate steps were followed.Another norian drillable inject was used and everything worked appropriately.It is unknown if there was a surgical delay.Patient outcome is unknown.This report is for a norian drillable inject 3cc-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: NORIAN DRILLABLE INJECT 3CC-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: 7736270
• Report Number: 2939274-2018-53146
• Device Sequence Number: 1018297
• Product Code: MQV
• UDI-Device Identifier: 10886982131607
• UDI-Public: (01)10886982131607
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 07/16/2018

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 Expiration Date: 08/28/2019
• Device Model Number: 07.704.003S
• Device Catalogue Number: 07.704.003S
• Device Lot Number: DSE6933
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 07/31/2018
• Patient Sequence Number: 1