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

Model Number	PS10.0-80SJ265
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not yet been returned for investigation.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that patient underwent a revision procedure on (b)(6) 2020 due to a broken nail.No patient injury was reported.
Event or Problem Description
See updated information in d4, d10, h2, h3, h6 and h10.
Additional Manufacturer Narrative
The nail was received for visual and functional testing.Reported lot #9031311aaa di not match the received nail lot # 9060609.The report is based on the received nail, visual inspection revealed that the returned product confirmed the nail was broken so the reported failure mode was confirmed.Functional testing could not be performed due to the condition of the nail.The device history review (dhr) was reviewed and showed the device was manufactured in accordance with the specified requirements and met all required quality inspections prior to shipment, based on the information provided and the type of breakage observed, it is possible that the nail broke due to stress generated from weight bearing activities.Per the precice styde instructions for use (ifu), " the precice stryde nail cannot withstand the stresses of full weight bearing.Patients should utilize external support and/or restrict activities as directed by the physician until consolidation occurs.".

• 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: 10255475
• Report Number: 3006179046-2020-00339
• Device Sequence Number: 16332168
• Product Code: HSB
• UDI-Device Identifier: 00887517951601
• UDI-Public: 887517951601
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PS10.0-80SJ265
• Device Lot Number: 9060609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 50 YR
• Patient Weight: 70