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

Model Number BT115-10D380-7

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted upon completion of the investigation.

Event Description

Information was received that a revision procedure was performed in (b)(6) 2021 after the patient fell twice on the operated side, resulting in the nail breaking.It was reported that prior to the fall, the nail had performed as intended and the patient bone had consolidated.There was no report of nail malfunction.The broken nail was replaced with a trauma nail.

Event Description

No additional information.

Manufacturer Narrative

No device evaluation can be performed as it is impossible to track the device.Based off the information that was received by the patient the potential root cause of the reported event was due to patient activity.The instructions for use (ifu) states that patients should utilize external support and/or restrict activities as directed by the physician until consolidation occurs.Although a device evaluation is not possible, a device history review (dhr) was performed on lot number: 9021512 and there were no deviations in the manufacturing process and the finished product met all acceptance criteria prior to shipment.

• Brand Name: PRECICE BONE TRANSPORT SYSTEM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11613459
• MDR Text Key: 255368987
• Report Number: 3006179046-2021-00218
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517979469
• UDI-Public: 887517979469
• Combination Product (y/n): N
• PMA/PMN Number: K201567
• 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: 07/23/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: BT115-10D380-7
• Device Lot Number: 9021512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 07/23/2021
• Supplement Dates FDA Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 18 YR
• Patient Weight: 60