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

Model Number	BT115-10SJ360-7
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation.Radiographs provided confirmed the alleged event.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that a removal surgery was completed in (b)(6) of 2019.As per reporter, the patient developed an infection (non-implant related) and the surgeon needed to remove the nail and put on external fixation.A few days later, for follow up of the external fixation pins, it was observed on x-rays that the bone transport nail had disassociated during the removal process and some of the components were left behind in the patient.
Additional Manufacturer Narrative
The nail was received for visual and functional testing.Visual inspection revealed scratches on the housing tube and a gap between the end cap and housing tube.The nail was functionally tested and was able to retract and distract.Force testing could not be performed due to the gap between the end cap and housing tube.An internal investigation revealed that the retention of the distal plug component into the housing tube was not sufficient to withstand the impaction forces placed on the implant during implant removal.In order to mitigate this failure mode, nuvasive specialized orthhpedics (nso) developed a single-use instrument to be used during removal surgery.The single-use instrument is utilized after removal of the distal locking screws by placing a plug into the distal hole in order to retain the distal plug component of the implant.

• Brand Name: PRECICE BONE TRANSPORT SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9298653
• Report Number: 3006179046-2019-00173
• Device Sequence Number: 16295323
• Product Code: HSB
• UDI-Device Identifier: 00887517979063
• UDI-Public: 887517979063
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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: 02/28/2021
• Device Model Number: BT115-10SJ360-7
• Device Catalogue Number: BT115-10SJ360-7
• Device Lot Number: 9030706AAA
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 07/09/2020
• 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: Other