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

Model Number	BT115-10SJ400-7
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Mo additional information has been provided.
Additional Manufacturer Narrative
The device was returned to the manufacturer for evaluation and visual and functional testing was performed.Visual inspection revealed no damage to the device.Functional testing was performed and the device passed all tests.The reported event of failure to distract was unable to be confirmed as the device functioned as intended.A review of the dhr documents indicates the device was manufactured by the specified requirement at the time and met all of the required inspections before shipment.
Event or Problem Description
Information was received that during the implant procedure the hospital did not have the right s-guide for the nail.The nail was cleaned and saved for implant a few days later.Before implanting the nail again, it was tested with the fast distractor and it would not distract.A new nail was used and the surgery was successfully completed.
Additional Manufacturer Narrative
Device has not been returned for evaluation and no additional information has been provided.The root cause is unable to be determined at this time.

• 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
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer Contact: patrick yrigoyen ; 101 enterprise suite 100; aliso viejo, CA 92656 ; 8583442667
• MDR Report Key: 19493912
• Report Number: 3006179046-2024-00136
• Device Sequence Number: 7037260
• Product Code: HSB
• UDI-Device Identifier: 00887517979025
• UDI-Public: 887517979025
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: BT115-10SJ400-7
• Device Lot Number: 2061513AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 06/08/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown