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

Model Number	PS10.0-65SJ250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the patient developed a bony fistula at the junction of the male/female port.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Corrected data: d4, h6 (impact code).Additional data: device evaluation: in an effort to complete a thorough investigation, due diligence was completed to obtain x-ray images of the reported bony fistula, however, the reporter was unresponsive.The reported event is unable to be confirmed.Upon return, visual inspection of the nail revealed the distraction rod portion of the nail had visible evidence of discoloration.Material discoloration/corrosion is currently being investigated through the capa process.Utilizing external assessments and standard corrosion test methods (salt spray), conclude that mechanically assisted crevice corrosion (macc) is the likely direct cause.The key element has been the mechanical micro-movement within the anti-rotation junction of the devices due to the higher weight bearing potential as a result of a more mobile patient population.We have been able to replicate this in-vitro and have developed the mechanical parameters that drive the clinical variation in corrosion.In-vitro testing has shown a correlation between the load on the telescopic junction of the device and the degree of corrosion, with much less corrosion seen at lower loads.This helps explain why different levels of corrosion between patients as weight bearing protocols vary among surgeons.A root cause analysis was performed and found the risks associated with mechanically assisted crevice corrosion (macc) were not adequately identified and mitigated through the risk management/design control process.Device records review: a review of device history records (dhr) for the returned unit confirmed that it met all the required quality inspections prior to release.In addition, the nail listed in this complaint was built prior to the initiation of the capa.
Event or Problem Description
X-ray images have been provided.

• Brand Name: PRECICE STRYDE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 13011029
• Report Number: 3006179046-2021-00515
• Device Sequence Number: 1727305
• Product Code: HSB
• UDI-Device Identifier: 00887517951588
• UDI-Public: 887517951588
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 03/10/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: PS10.0-65SJ250
• Device Lot Number: 0061204AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• 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: 12/08/2021
• Supplement Date Received by Manufacturer: 02/28/2022; 03/10/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/28/2022; 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2020
• 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: Required Intervention
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 63 KG