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

Model Number	PS11.5-50SJ235
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
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.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the nail is broken.No patient adverse event was reported.
Event or Problem Description
No additional information provided.
Additional Manufacturer Narrative
Visual inspection of the nail confirmed the reported issue of a broken nail.Broken nails are a known issue and can occur when the implanted nail is subjected to undue stress due to the patient¿s activities.A device history review (dhr) was performed on lot number 8082301aaa and there were no deviations in the manufacturing process and the finished product met all acceptance criteria prior to shipment.Complaint has no change orders (co) or capas.

• 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: 12356652
• Report Number: 3006179046-2021-00449
• Device Sequence Number: 20037472
• Product Code: HSB
• UDI-Device Identifier: 00887517951656
• UDI-Public: 887517951656
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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: PS11.5-50SJ235
• Device Lot Number: 8082301AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 70