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

Model Number	BT115-10X380-7
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.Images provided confirmed the alleged event.Root cause is unable to be determined at this time.The reported event has been addressed in the device labeling.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter, while trying to reset the nail during a revision procedure for a screw exchange the nail transport shaft could not be moved after many attempts.No patient injury was reported.
Event or Problem Description
No additional event information provided.
Additional Manufacturer Narrative
The customer¿s report was not confirmed.The returned bone transport nail was functionally tested, and no anomalies were found.Retraction and distraction force measurement was found to be within specification.A review of dhr (device history record) for the returned unit confirmed that it met all the required quality inspection criteria (x-ray inspection and acceptance test).The root cause of the customer¿s report could not be identified.

• 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: 11033811
• Report Number: 3006179046-2020-00501
• Device Sequence Number: 11021407
• Product Code: HSB
• UDI-Device Identifier: 00887517978929
• UDI-Public: 887517978929
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K201567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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 Expiration Date: 01/31/2022
• Device Model Number: BT115-10X380-7
• Device Lot Number: 0020502AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 03/26/2021
• 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