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

Model Number PS10.0-80D265

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2021

Event Type  malfunction  

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 Description

Information was received that upon explant the nail was noted to have crevice corrosion at the junction site of the male and female components between the screws and screw holes of the nail.No patient adverse event was reported.

Event Description

No additional information was reported.

Manufacturer Narrative

Device evaluation: upon return, visual inspection of the nail revealed the junction site of the male and female components between the screws and screw holes of the nail had visible evidence of discoloration.Utilizing external assessments and standard corrosion test methods (salt spray), our investigation has identified mechanically assisted crevice corrosion (macc) as the likely direct cause.The key element has been the mechanical micro-movement within the anti-rotation junction of the stryde 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: review of the device history records indicated the precice-stryde nail was visually inspected,functionally tested, and met all required specifications prior to release.

• Brand Name: PRECICE STRYDE SYSTEM
• Type of Device: 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 92656 ; 8583448112
• MDR Report Key: 12848916
• MDR Text Key: 282405845
• Report Number: 3006179046-2021-00497
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517951182
• UDI-Public: 887517951182
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS10.0-80D265
• Device Lot Number: 9031308AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male