MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE STRYDE SYSTEM; FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY

Model Number	STP4-325
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation as it remains in-situ.Radiographs provided confirmed the alleged event.No root cause can be confirmed as the device will not be returned per surgeon's decision to forego revision surgery.
Event or Problem Description
Information was received that a patient fractured his distal screws that had been revised on (b)(6) 2019.There is no revision procedure planned at this time.
Additional Manufacturer Narrative
Visual inspection of the screws revealed both to be broken.Functional testing was unable to be performed as product was damaged.The maximum patient weight for a 10mm nail diameter is 150 pounds and the reported weight of the patient was 182 pounds which exceeds the maximum.Even though root cause cannot be confirmed, based on information provided the potential root cause may be related to implantation of the incorrect nail size for the patient's weight.

• Brand Name: PRECICE STRYDE SYSTEM
• Common Device Name: FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9777398
• Report Number: 3006179046-2020-00123
• Device Sequence Number: 2574546
• Product Code: HSB
• UDI-Device Identifier: 00887517952363
• UDI-Public: 887517952363
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2020

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: STP4-325
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 06/24/2020
• 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: Other
• Patient Age: 17 YR
• Patient Weight: 80