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	Chemical Problem (2893)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2021, the norian drillable inject 3cc was mixed with rotary mixer in a case.All steps were followed properly, temperature indicator was good as well as expiration date; however, no injectable bone void filler came out when it was pulled.There was a surgical delay of fifteen (15) minutes.The procedure was successfully completed.There was no patient consequence.This report involves one (1) norian drillable inject 3cc-sterile.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
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.H3, h6: the subject device has been 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.
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.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.Part # 07.704.003s, synthes lot # ds7008141, supplier lot # ds7008141, release to warehouse date: 30 sep 2021, expiration date: 28 jul 2023, supplier: (b)(4).No ncr's were generated during production.The product was returned to depuy synthes for evaluation.The depuy synthes team forwarded the device to dsm where a visual inspection of the returned device was conducted.Dsm reviewed all related device history records and risk documentation associated with the complaint condition which reported that bone void filler did not dispense from the pouch after mixing.The returned pouch was observed to have a cracked luer lock on the rotary pouch where the solution syringe is attached.Hardened material in pouch indicated that solution was injected and a reaction occurred.However, due to the failure to dispense identified in the complaint description it is assumed that an inadequate amount of solution was injected as a result of the cracked luer.There were no discrepancies related to this failure mode during the manufacturing of the lot from which the product was received.The crack in the luer was visible during an inspection of the pouch and consisted of a crack along the length of the luer lock.A dimensional inspection was unable to be performed due to not being applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the norian drillable inject 3cc-sterile, p/n: 07.704.003s would contribute to the complained device issue.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.If information is obtained that was not available for this 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
• 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: 13254377
• Report Number: 2939274-2022-00169
• Device Sequence Number: 4593793
• Product Code: MQV
• UDI-Device Identifier: 10886982131607
• UDI-Public: (01)10886982131607
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 07.704.003S
• Device Catalogue Number: 07.704.003S
• Device Lot Number: DS7008141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 02/04/2022; 11/24/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 03/03/2022; 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown