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

Model Number	PS10.0-80D335
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned as it remains in-situ.Root cause is unable to be determined at this time.
Event or Problem Description
Information was received that x-ray images revealed that the nail was broken.As per the surgeon, the nail is broken over the extension so the nail will not be revised.There was no patient injury reported.
Additional Manufacturer Narrative
Nail lot number 190513-19 was received for visual and functional testing.Visual inspection of the received nail confirmed the reported issue of the nail being broken.A device history review (dhr) was performed and there were no deviations in the manufacturing process and the finished product met all acceptance criteria prior to shipment.Functional testing was not performed and the nail functioned as intended for the entire procedure.Based on the information provide, no event had occurred which could have led to the nail breaking.However, based on the information provided, it is possible that the nail broke due to the stress generated from weight bearing activities.Per the precice stryde instructions for use (ifu) ".The nail cannot withstand the stresses of full weight bearing.Patient should utilize external support and/or restrict activities as directed by the physician until consolidation occurs.".
Additional Manufacturer Narrative
Lot number 9070209aaa was received for visual and functional testing, not lot 190513-19 as stated in the previous report.
Event or Problem Description
See corrected information in h10.

• 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: 10902044
• Report Number: 3006179046-2020-00489
• Device Sequence Number: 14121061
• Product Code: HSB
• UDI-Device Identifier: 00887517951212
• UDI-Public: 887517951212
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2021

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: PS10.0-80D335
• Device Lot Number: 9071907AAA
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 03/01/2021; 03/08/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 03/03/2021; 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1