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

Model Number	PS11.5-80SJ265
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is in progress; upon completion, a follow-up medwatch will be submitted.
Event or Problem Description
It was reported that upon removal of the nail after it had achieved its intended purpose and outcome, it was noted that there were changes to the metal on the distal screw hole at the junction of the nail.No patient impact or adverse event was reported.
Event or Problem Description
No additional event information was provided.
Additional Manufacturer Narrative
Additional data: d8, h3, h6, h10.Correction: d4.Device records review: a review of dhr for the returned unit confirmed that it met all the required quality inspection criteria prior to release.Device evaluation: visual inspection of the returned nail revealed that the distraction rod of the nail had corrosion.The root cause cannot be determined at this time; further investigation is being conducted through the capa process.

• Brand Name: PRECICE STRYDE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11499537
• Report Number: 3006179046-2021-00201
• Device Sequence Number: 5257578
• Product Code: HSB
• UDI-Device Identifier: 00887517951670
• UDI-Public: 887517951670
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: PS11.5-80SJ265
• Device Lot Number: 9022548AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1