MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NORIAN DRILLABLE INJECT 5CC-STERILE; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	07.704.005S
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant device is expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 an unknown date, an issue with the 5cc inject.While solution was injected into the pouch, some but not all solution started leaking out of the side of the lure lock.After running the rotary mixer for 70 seconds, they tried to moved the putty into the syringe and nothing loaded into the syringe at all.This did not affect patient care as they had another 5cc were able to use.And was able to hold onto the pouch.It is unknown when was the issue discovered.Patient and procedure involvement are unknown.This complaint involves one (1) device.This report is for one (1) norian drillable inject 5cc-sterile.This report is 1 of 1 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.Customer quality investigation: the device was not returned.A photo-investigation was performed on the images located in pc attachment ¿(b)(4) intake email with device image received from sales consultant.Msg 24may2021".Upon inspecting the images provided, the reported condition of leakage couldn¿t be confirmed.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.Conclusion: the complaint condition couldn¿t be confirmed during photo investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot - part # 07.704.005s, synthes lot # ds7006408, supplier lot # ds7006408, release to warehouse date: 05 mar 2021 , expiration date: 28 dec 2022, supplier: (b)(4), no ncr's 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 5CC-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
• MDR Report Key: 12016369
• Report Number: 2939274-2021-03007
• Device Sequence Number: 4256945
• Product Code: MQV
• UDI-Device Identifier: 10886982131614
• UDI-Public: (01)10886982131614
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 05/24/2021

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: 12/28/2022
• Device Model Number: 07.704.005S
• Device Catalogue Number: 07.704.005S
• Device Lot Number: DS7006408
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1