MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS PRECICE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	CPA2-005
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and is pending evaluation.The root cause is unable to be determined at this time.A supplemental report will be submitted following the device evaluation.
Event or Problem Description
Information was received that after a successful nail implant procedure, the patient reported that they felt discomfort and it hurt to flex their knee.The surgeon determined that a revision procedure would be performed to remove the end cap that was placed.During the procedure, the surgeon was unsuccessful in removing the end cap.At a later date, a second revision procedure was performed.Multiple attempts were made to remove the end cap; however, they were unsuccessful.It was then determined that the nail would need to be removed and replaced.
Additional Manufacturer Narrative
Visual inspection of the nail determined the end cap to have experienced significant damage.The pilot hole for hex on the end cap was completely destroyed; it appeared the end cap suffered excessive applied force.There was no visible sign of cold welding.The end cap was removed from the nail and inspection revealed no damage within the end cap or to the tube threads.Upon opening the end cap, bone fragments were found inside.It is likely the surgical site wasn't irrigated to remove the remaining bone fragments from the housing tube during the installation of the end cap.Due to the fragments not being removed, the end cap was over torqued as well as bone fragments within, which caused the end cap to become stuck in the housing tube.The work order was reviewed and the device had passed all quality inspections per acceptance tests prior to being shipped.Also, the iqc inspection data for the lot of end cap was reviewed and confirmed indicated part met design specifications per the engineering drawings.
Event or Problem Description
No additional information was provided.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise #100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 13595310
• Report Number: 3006179046-2022-00126
• Device Sequence Number: 1969270
• Product Code: HSB
• UDI-Device Identifier: 00887517001146
• UDI-Public: 887517001146
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CPA2-005
• Device Lot Number: 9100861-AAE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown