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

Model Number	BT115-10D380-7
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in progress.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Information was received that a revision procedure was performed in (b)(6) 2021 after the patient fell twice on the operated side, resulting in the nail breaking.It was reported that prior to the fall, the nail had performed as intended and the patient bone had consolidated.There was no report of nail malfunction.The broken nail was replaced with a trauma nail.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
No device evaluation can be performed as it is impossible to track the device.Based off the information that was received by the patient the potential root cause of the reported event was due to patient activity.The instructions for use (ifu) states that patients should utilize external support and/or restrict activities as directed by the physician until consolidation occurs.Although a device evaluation is not possible, a device history review (dhr) was performed on lot number: 9021512 and there were no deviations in the manufacturing process and the finished product met all acceptance criteria prior to shipment.

• 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: 11613459
• Report Number: 3006179046-2021-00218
• Device Sequence Number: 3099849
• Product Code: HSB
• UDI-Device Identifier: 00887517979469
• UDI-Public: 887517979469
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: BT115-10D380-7
• Device Lot Number: 9021512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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; Required Intervention
• Patient Age: 18 YR
• Patient Weight: 60