MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NORIAN DRILLABLE INJECT 3CC-STERILE; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Model Number	07.704.003S
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j employee.Device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 unknown date, the two extra boxes of norian drillable inject needed to be opened because the nurse forgot to squeegee the norian into the syringe.Two (2) norian drillable inject cracked when attaching the syringe to the pouch.It was unknown when the issue when discovered.Patient and procedure involvement are unknown.This report is for one (1) norian drillable inject 3cc-sterile.This is report 3 of 3 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.H3, h6: a product investigation was conducted.Visual inspection: the norian drillable inject 3 cc- sterile (p/n: 07.704.003s, lot #: ds7001509) was returned and received.Upon visual inspection, the pouch was noted to be opened at the chevron end and the syringe was disconnected.Hardened material was observed in the rotary pouch indicating that the solution was injected and a reaction occurred.There were no observations to indicate that the material would not have been able to transfer to the delivery syringe if it was not removed prematurely.No other issues were observed with the returned components.Functional test: a functional test was not performed due to opened pouch and syringe disconnected.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 3 cc- sterile (p/n: 07.704.003s, lot #: ds7001509).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.There were no observations to indicate that the material would not have been able to transfer to the delivery syringe if it was not removed prematurely.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: dsm biomedical - kensey nash.Inspection and release by: monument part number: 07.704.003s - norian drillable inject 3cc - sterile, lot number: ds7001509 (sterile), lot quantity: (b)(4) , release to warehouse date: 05-dec-2018, expiration date: 28-mar-2020.Purchased finished goods traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of conformance received from dsm dated 27-nov-2018 was reviewed and determined to be conforming.Certificate of conformance sterility parameters 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 3CC-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: 11599849
• Report Number: 2939274-2021-01642
• Device Sequence Number: 3402717
• Product Code: MQV
• UDI-Device Identifier: 10886982131607
• UDI-Public: 10886982131607
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: 03/28/2020
• Device Model Number: 07.704.003S
• Device Catalogue Number: 07.704.003S
• Device Lot Number: DS70006264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/27/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NORIAN DRILLABLE INJECT 10CC-STERILE; NORIAN DRILLABLE INJECT 5CC-STERILE