MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NORIAN DRILLABLE INJECT 10CC-STERILE; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Model Number	07.704.010S
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.The 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 10cc-sterile.This is report 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6 - codes updated to imdrf codes.Device history lot - manufacturing location: supplier - dsm biomedical - (b)(6) / inspected and released by: monument release to warehouse date: 11-may-2020 expiration date: 28-feb-2022 part number: 07.704.01ss, norian drillable inject 10cc¿ sterile lot number: ds7004881 (sterile) lot quantity: 150 purchased finished goods traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, (b)(6) rev u met all inspection acceptance criteria.Certificate of conformance received from dsm dated 05-may-2020 was reviewed and determined to be conforming.Sterility requirements on certificate 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 history review - 19-mar-2021: dhr reviewed by: (b)(6).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, CALCIUM SULFATE PREFORMED PELLETS
• 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: 11599871
• Report Number: 2939274-2021-01643
• Device Sequence Number: 19683699
• Product Code: MQV
• UDI-Device Identifier: 10886982131621
• UDI-Public: 10886982131621
• 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: 02/28/2022
• Device Model Number: 07.704.010S
• Device Catalogue Number: 07.704.010S
• Device Lot Number: DS7004881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NORIAN DRILLABLE INJECT 3CC-STERILE; NORIAN DRILLABLE INJECT 5CC-STERILE
• Patient Sex: Unknown