MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NORIAN DRILLABLE INJECT 10CC-STERILE; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	07.704.010S
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.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.
Event or Problem Description
It was reported that on (b)(6) 2022, patient underwent a unknown procedure.In a bilateral calcaneus fracture case we went to put 10cc's of norian in one side.While mixing the doc broke off the anterior process of the calcaneus and i went running for plates.In this time the norian was opened without having been rolled into the syringe and was left to harden in the package.We ultimately opened another box and used that successfully.The procedure was successfully completed with a 3 minutes of surgical delay noted.Patient status is unknown.This complaint involves one (1) device norian drillable inject 10cc-sterile.This is report 1 of 1 for complaint (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.H3, h4, h6: visual analysis of the photo revealed that norian drillable inject 10cc-sterile (product code: 07.704.010s) had no issue that can be traced to the product based on evidence available on picture provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for norian drillable inject 10cc-sterile (product code: 07.704.010s).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: part# 07.704.010s.Synthes lot# ds7008038.Supplier lot# ds7008038.Release to warehouse date: 28 oct2021, 30 oct2021.Expiration date: 28 jul2023.Supplier: (b)(4).No ncrs were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13660630
• Report Number: 2939274-2022-00749
• Device Sequence Number: 20066277
• Product Code: MQV
• UDI-Device Identifier: 10886982131621
• UDI-Public: 10886982131621
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K102722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 07/28/2023
• Device Model Number: 07.704.010S
• Device Catalogue Number: 07.704.010S
• Device Lot Number: DS7008038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown