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

Model Number	BT13-10B400-7
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for investigation.Root cause is unknown at this time.
Event or Problem Description
Information was received that during implantation of the nail, the nail was inserted and taken out when marking the corticotomy location.During reinsertion of the nail it was noticed the nail had disassociated.The nail was able to be retrieved.No patient injury was reported.
Additional Manufacturer Narrative
The nail was received for visual and functional testing.Visual inspection revealed that the nail was disassociated from the housing tube.Based on visual inspection the reported failure mode was confirmed.Due to the condition of the nail, x-rays and functional testing were unable to be performed.A device history review (dhr) was performed on lot number 0031928aaa and there were no deviations in the manufacturing process and the finished product met all acceptance criteria prior to shipment.
Event or Problem Description
N/a.

• 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: 10632248
• Report Number: 3006179046-2020-00402
• Device Sequence Number: 1179156
• Product Code: HSB
• UDI-Device Identifier: 00887517977809
• UDI-Public: 887517977809
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/29/2021

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: BT13-10B400-7
• Device Lot Number: 0031928
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 110