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

Model Number	PS11.5-80D265
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation nor were x-rays provided to confirm the alleged event.Root cause is unable to be determined at this time.The reported event has been addressed in the device labeling.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter the nail was found to be fractured during a follow up appointment.No patient injury was reported.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter the nail was found to be fractured during a follow up appointment.Desired lengthening was achieved; however, there was delayed healing and the broken nail was exchanged for a trauma nail.
Additional Manufacturer Narrative
Additional data: b5, d8, d9, h3, h4, h6, h10.Correction: h1.Device records review: a device history review was conducted and found no deviations, non-conformances, or other manufacturing issues related to the reported event.Device evaluation: visual inspection of the returned product revealed that the housing tube was broken at the bottom side of the second screw hole.Based on the reported information, no event in particular was noted to have occurred that led to the nail breaking; however, based on the type of breakage observed, it is probable that the nail broke due to stress generated from weight bearing activities.Per the precice stryde instructions for use, "the precise 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: 11033913
• Report Number: 3006179046-2020-00507
• Device Sequence Number: 16402503
• Product Code: HSB
• UDI-Device Identifier: 00887517951250
• UDI-Public: 887517951250
• 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): 04/01/2021

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: PS11.5-80D265
• Device Lot Number: 9090603AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/29/2020
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 04/01/2021
• 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: 16 YR
• Patient Weight: 45