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
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not available for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Initial reporter is synthes sales consultant.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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 a hand surgery on (b)(6) 2018, the norian drillable inject 5cc solution was properly mixed but failed to transfer into the syringe needle.The norian drillable inject was not used.A second norian drillable inject was opened and used to complete the procedure.It was unknown if there was a surgical delay.Patient status and surgical outcome are unknown.This report is for one (1) norian drillable inject 5cc.This is report 1 of 1 for (b)(4).
Additional 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.Additional narrative: date of manufacture 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.
Additional 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.Additional narrative: device history records review was completed for part# 07.704.005s, lot# dse6761.Manufacturer: dsm biomedical - kensey nash, release to warehouse date: nov 30, 2017, expiry date: jul 28, 2019.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 investigation was completed.The norian drillable was received with cement present in the rotary pouch.There is some cement present in the delivery syringe and the remainder of the cement is in the pouch at the interface with the syringe.The complaint was not able to be replicated because a functional test could not be completed as the cement has already hardened with in the rotary pouch.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional analysis is not applicable due to the returned condition of the product, hardened cement within the pouch.Relevant drawings were reviewed.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 that the cement was not implanted within the 5-minute maximum time frame refenced in the relevant technique guide, norian drillable inject surgical technique.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
• 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: 7677739
• Report Number: 2939274-2018-52807
• Device Sequence Number: 13841448
• Product Code: MQV
• UDI-Device Identifier: 10886982131614
• UDI-Public: (01)10886982131614
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Caregivers
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2018

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: 07/28/2019
• Device Model Number: 07.704.005S
• Device Catalogue Number: 07.704.005S
• Device Lot Number: DSE6761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 07/11/2018; 07/20/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 07/12/2018; 07/31/2018
• Patient Sequence Number: 1