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

Model Number	BT13-10X400-7
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation therefore, no root cause can be confirmed at this time.No product returned as it is in-situ.
Event or Problem Description
Information was received that a removal procedure would be performed and external fixation placed since the patient was not consolidating.As per the reporter, the nail was not working.
Additional Manufacturer Narrative
The customer¿s report that the patient¿s bone segment was not transporting and the nail was not working was not confirmed based on visual inspection and functional testing.As part of the investigation the entire manufacturing process was reviewed.What was discovered was the shimming fixture during testing was missing a component.Due to the missing component, this resulted in an insufficient amount of axial space for the internal components.This is a manufacturing issue and is being addressed in an internal investigation.
Event or Problem Description
See updated information in h2, h3, h6 and h10.

• Brand Name: PRECICE BONE TRANSPORT SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 10113075
• Report Number: 3006179046-2020-00322
• Device Sequence Number: 14158973
• Product Code: HSB
• UDI-Device Identifier: 00887517977083
• UDI-Public: 887517977083
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K182170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: BT13-10X400-7
• Device Lot Number: 0010308
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 01/13/2021
• 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: 55 YR
• Patient Weight: 91