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

Model Number	BT115-10SJ400-7
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
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 x-ray images showed the nail had broken in-situ.The patient was full weight bearing on the nail as a builder post consolidation.The nail has been explanted.There was no patient injury as a result of the reported event.
Additional Manufacturer Narrative
The nuvasive precice bone transport nail was not received for in person investigation.During visual evaluation of the provided x-rays and images, it was observed that the housing tube was broken, which confirmed the reported failure mode.The breakage was not determined to have been related to the manufacturing process or material failure.The probable cause of the failure is due to mechanical bending, in fatigue due to patient weight bearing activities.Per the eifu, contraindications include: "patients and/or families unwilling or incapable of following postoperative care instructions." 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 prior to product departure.
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; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise #100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 14803165
• Report Number: 3006179046-2022-00224
• Device Sequence Number: 4652942
• Product Code: HSB
• UDI-Device Identifier: 00887517979025
• UDI-Public: 887517979025
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K193016
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: BT115-10SJ400-7
• Device Lot Number: 0021901AAA
• Was Device Available for Evaluation?: No
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose