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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that during explantation, a broken nail and fixation screw were observed.No patient impact was reported.Report 1 of 2.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned unit confirmed the reported issue with the nail being bent and fractured at one side of the intercalary slot.A definitive cause for the fracture is unknown but the location and nature of the fracture is consistent with mechanical bending/material fatigue caused by excessive patient weight bearing activities.Device records review: review of the device history record for the nail confirmed that it met all of the required quality inspection and release criteria.Label review: ".Warnings: the precise bone transport system cannot withstand the stresses of full weight bearing.The patient should progressively weight bear and use assistive devices as directed by the physician."."patients should utilize external support and/or restrict activities as directed by the physician until consolidation occurs."."metallic implants can loosen, fracture.".
Event or Problem Description
No additional information was provided.

• 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: 12131903
• Report Number: 3006179046-2021-00356
• Device Sequence Number: 14633634
• Product Code: HSB
• UDI-Device Identifier: 00887517979063
• UDI-Public: 887517979063
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: BT115-10SJ360-7
• Device Lot Number: 0042406AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1