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

Model Number 07.704.010S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Patient weight was not provided for reporting.Device malfunctioned intraoperative.Device was not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.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 Description

It was reported that on (b)(6) 2018, patient underwent a foot surgery.During the surgery, a 10cc pouch of norian drillable injectable bone void filler did not mix to the correct consistency.It was too ¿watery¿ and was unable to be used.The 10cc norian product was discarded.Two 5cc pouches of norian drillable were opened and mixed together and were the proper consistency.The surgery was completed successfully, with no surgical delay.No reported harm to the patient.Patient outcome was reported as good.This report is for one (1) norian drillable inject 10cc-sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A device history record (dhr) review was conducted: manufacturing location: (b)(4).Packaged by: (b)(4), manufacturing date: 30-nov-2017, expiration date: 28-jun-2019: part #: 07.704.010s, lot#: dse6844 (sterile) - norian drillable inject 10cc - sterile.Quantity (b)(4).: inspection sheet for incoming final inspection met inspection acceptance criteria.Certificate of conformance received from dsm meet specification.No non-conformance reports (ncrs) were generated during production.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.Sterility documentation was reviewed and determined to be conforming.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.

• Brand Name: NORIAN DRILLABLE INJECT 10CC-STERILE
• Type of Device: 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: 7499478
• MDR Text Key: 107957930
• Report Number: 2939274-2018-52115
• Device Sequence Number: 1
• Product Code: MQV
• UDI-Device Identifier: 10886982131621
• UDI-Public: (01)10886982131621
• Combination Product (y/n): N
• PMA/PMN Number: K102722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: 07.704.010S
• Device Catalogue Number: 07.704.010S
• Device Lot Number: DSE6844
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR