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

Model Number	BT10-90B340-5
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.Root cause is unable to be determined at this time.If relevant additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that a revision procedure was performed due to the patient suffering from a peri-prosthetic fracture around the proximal nail screws which resulted in a loss of alignment.Additionally, during removal of the nail, the nail disassociated.It was reported that instead of a retention plug, the surgeon used a unilateral external fixator to hold all segments during nail removal, with the proximal apex pin inserted in close proximity to the nail.

• Brand Name: PRECICE BONE TRANSPORT 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: 11592875
• Report Number: 3006179046-2021-00214
• Device Sequence Number: 17030865
• Product Code: HSB
• UDI-Device Identifier: 00887517979995
• UDI-Public: 887517979995
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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: BT10-90B340-5
• Device Lot Number: 0012240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/30/2021
• 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: Required Intervention
• Patient Age: 28 YR
• Patient Weight: 86