MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NORIAN DRILLABLE INJECT 5CC-STERILE; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Model Number	07.704.005S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional narrative: patent identifier: (b)(6).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; 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 (b)(6) 2021, the patient underwent for a procedure.During the procedure, the norian mixing solution leaked out while injecting.The procedure was concluded using a new 10cc norian kit.There were three (3) minutes of surgical delay.The procedure was successfully completed.There was no patient consequence reported.This complaint involves one (1) device.This report is for (1) norian drillable inject 5cc-sterile.This is report 1 of 1 or complaint (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.H10 additional narrative: h3, h6: part: 07.704.005s.Synthes lot: ds7004294.Supplier lot: n/a.Release to warehouse date: july 20, 2020.Expiration date: n/a.Supplier: (b)(4).No nonconformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Visual inspection: the norian drillable inject 5cc-sterile 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.- norian reinforced.Investigation conclusion: the complaint condition was confirmed for the norian drillable inject 5cc-sterile as the luer lock was cracked leading to the leakage of the cement while injecting.The root cause for the reported issue is attributed to a manufacturing related issue.Relevant actions have been taken to address the issue.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.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, 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: 12956777
• Report Number: 2939274-2021-06988
• Device Sequence Number: 13885206
• Product Code: MQV
• UDI-Device Identifier: 10886982131614
• UDI-Public: (01)10886982131614
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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 Model Number: 07.704.005S
• Device Catalogue Number: 07.704.005S
• Device Lot Number: DS7004294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male