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

Model Number BT115-10SJ360-7

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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 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.

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
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9298653
• MDR Text Key: 166128225
• Report Number: 3006179046-2019-00173
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517979063
• UDI-Public: 887517979063
• Combination Product (y/n): N
• PMA/PMN Number: K182170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other