MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NORIAN DRILLABLE INJECT 5CC-STERILE; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Model Number 07.704.005S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Due to intra-operative issues, the device was not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.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 during an unknown orthopedic procedure on (b)(6) 2018, the plastic end of the 5cc norian drillable inject was damaged while attempting to mix a 5cc of norian product.When the nurse went to inject the solution in the syringe to the mixer pouch, the plastic lure lock was engaged to tight and damaged the lure lock on the syringe.This may have been caused by spinning too fast.Instead, a 10cc norian drillable product was used.There was no patient consequence reported.There was a surgical delay of less than five (5) minutes.The surgery was completed successfully.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history records review was completed for part# 07.704.005s, lot# dse8241.Manufacturer: dsm biomedical- kensey nash, manufacturing date: jan 31, 2018, expiry date: nov 30, 2019.Certificate of conformance received from dsm biomedical inc.Certifies the items were manufactured in accordance to the material and/or industry specifications per the product drawing(s) and purchase order.Inspection requirements were performed and passed.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.The norian drillable was received at us cq with cement present in the rotary pouch as well as damage to the luer lock and a crack in the sodium hyaluronate solution component syringe.The complaint is confirmed.The complaint was not able to be replicated because a functional test could not be completed as the components are already mixed and cement has hardened with in the rotary pouch.This is consistent with the reported complaint condition.Dimensional analysis is not applicable due to the returned condition of the product, hardened cement within the pouch.Relevant drawings were reviewed.The complaint condition is confirmed as the norian drillable was received with damage to the luer lock as well as a crack in the sodium hyaluronate syringe.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is likely the luer lock was damaged and the syringe was cracked upon assembly, possibly due to incorrect or forceful assembly.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7610848
• MDR Text Key: 112001915
• Report Number: 2939274-2018-52528
• Device Sequence Number: 1
• Product Code: MQV
• UDI-Device Identifier: 10886982131614
• UDI-Public: (01)10886982131614
• 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: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 07.704.005S
• Device Catalogue Number: 07.704.005S
• Device Lot Number: DSE8241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1