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

Model Number	BT10-90SJ340-7
Medical Device Problem Codes	Fracture (1260); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation as it remains in-situ.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 while retracting the nail to see if it still worked, it was noted on the intra-operative x-rays, that the nail was broken into two segments.The nail was still functional, and the surgeon opted to retract the nail and leave it in-situ to continue bone transport of the patient's femur.No patient adverse event was reported.
Additional Manufacturer Narrative
The nail was not returned for investigation.During evaluation of the provided x-ray images, it was observed that the housing tube was broken, which confirmed the reported failure mode.The root cause of the failure could not be determined due to no device return; however, based off the location of the break and previous investigations, the root cause of the break is due to a mechanical bending failure and fatigue due to excessive stressed applied by the patient's daily activities.The iqc inspection data for the lot of the housing tube was reviewed and confirmed the part met design specifications per the engineering drawings.Review of the device history records indicated the unit met all quality specifications and testing requirements prior to product shipment.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
The cause of the failure is likely related to the reported off label usage, which allowed stress to be placed on over-extended nail, causing mechanical bending failure and fatigue, which led to the fracture.Per the bone transport ifu, contraindications include: patients with maximum bone defect of more than 100 mm.The ifu also details the maximum distance of treated limb surface to im canal for each size of nail.Should the device be received for evaluation, a supplemental report will be filed.
Event or Problem Description
Additional information was received that the broken nail was used off label and had been in the patient spanning a larger than indicated segment in the femur.The nail has been explanted.The surgeon was aware the product was being used off label.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned product confirmed that the housing tube was broken in two pieces which along with x-rays confirmed the reported failure.The reported nail was implanted for 567 days and has exceeded the guidelines within the instructions for use (ifu) for length of implantation.The reported breakage was not determined to have been related to the manufacturing processes or material failure.The probable cause of the failure is due to mechanical bending failure in fatigue due to the patient's weight bearing activities.Device labeling: per the ifu, the device should be removed after implantation time of no more than one year.
Event or Problem Description
No additional information has been provided.

• Brand Name: PRECICE BONE TRANSPORT SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise dr ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise dr ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 13938754
• Report Number: 3006179046-2022-00160
• Device Sequence Number: 4476309
• Product Code: HSB
• UDI-Device Identifier: 00887517979780
• UDI-Public: 887517979780
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K201567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/26/2022

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: BT10-90SJ340-7
• Device Lot Number: 0070101AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 04/11/2022; 05/19/2022; 08/24/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/18/2022; 06/15/2022; 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose