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	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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 or Problem Description
It was reported that on (b)(6) 2021, during an unknown procedure, the sh solution that supposed to inject into the norian bag would not inject.The solution kept shooting back out preventing the calcium phosphate from being hydrated.I checked the seal and re-attached the syringe but still could not get the solution to inject.A backup supply was used.There was no surgical delay.Procedure outcome is unknown.No patient consequence.This complaint involves one (1) device.This report is for one (1) norian drillable inject 10cc-sterile.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, a review of the device history records has been requested and is currently pending completion as product is entering the complaint system.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the norian drillable inject 10cc-sterile (part# 07.704.010s, lot# ds7006295) was returned and received at dsm biomedical.Upon visual inspection, it was observed that the material in the pouch had hardened indicating that some of the solution had been successfully injected and a reaction had occurred.The crack along the length of the luer lock was visible after close inspection.No other issues were observed with the returned device.Functional test: a functional test was not performed as it was observed that the luer lock was cracked thus confirming the complaint condition.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed investigation conclusion: the complaint condition was confirmed for the norian drillable inject 10cc-sterile (part# 07.704.010s, lot# ds7006295) as the luer lock was cracked leading to the leakage of the cement/solution while injecting.The root cause for the reported issue is attributed to a manufacturing related issue.Nr was initiated to track further investigation of this product failure.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.H3, h4, h6: a device history record (dhr) review was conducted: manufacturing location: supplier-dsm biomedical - kensey nash / final inspection and release: monument release to warehouse date: 01-mar-2021 expiration date: 28-nov-2022 part number: 07.704.010s, norian drillable inject 10cc - sterile lot number: ds7006295 (sterile) lot quantity: (b)(4) purchased finished goods travelers met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of conformance dated (b)(6) 2021 was reviewed and determined to be conforming.Certificate of conformance sterility requirements and results were reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that 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
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA
• MDR Report Key: 11613351
• Report Number: 2939274-2021-01677
• Device Sequence Number: 3196574
• Product Code: MQV
• UDI-Device Identifier: 10886982131621
• UDI-Public: (01)10886982131621
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 03/08/2021

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: 11/28/2022
• Device Model Number: 07.704.010S
• Device Catalogue Number: 07.704.010S
• Device Lot Number: DS7006295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/06/2021; 02/11/2022
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 04/30/2021; 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown