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

Model Number	BT10-10D380-7
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
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 the nail was explanted without the retention plug and it left the inner magnet behind.No additional information has been provided.
Additional Manufacturer Narrative
Additional data: b5, b6, d9, h3, h6, h10 device evaluation: upon receipt to nuvasive a visual inspection was conducted.It was observed that the nail had minor damage to the threads on the opposite side of the distal plug.It was visually confirmed that the internal components of the nail were physically missing.X-rays were taken of the nail and confirmed the fact that all of the internal components are missing which confirmed that the components were left inside of the patient as reported.Based on the investigation conducted and the information provided, it was determined that the failure is likely due to a design failure as well as the use of improper instrumentation to remove the nail and the patient's bone condition.A corrective and preventive action (capa) was initiated to address the design failure.As a result of the capa a retaining ring was added to the distal plug to help prevent disassociation from occurring.It is possible that if the surgeon had the retention plug at the time that the nail was taken out that the nail may have been easier to remove.It is also possible that even using the appropriate nuvasive removal instrument, the patient¿s bone condition would have still required excessive force to remove the nail, potentially leading to a disassociation.It should be noted that this nail was manufactured prior to the implantation of the capa.
Event or Problem Description
Additional information has been provided.
Event or Problem Description
Additional information has been provided.
Additional Manufacturer Narrative
A review of the device history record confirmed the device met all quality inspections and specifications prior to release.

• Brand Name: PRECICE BONE TRANSPORT SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 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: 17164693
• Report Number: 3006179046-2023-00305
• Device Sequence Number: 20231348
• Product Code: HSB
• UDI-Device Identifier: 00887517981288
• UDI-Public: 887517981288
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K201567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2023

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: BT10-10D380-7
• Device Lot Number: 0011307AAA
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 07/14/2023; 09/29/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 07/25/2023; 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• 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 Age: 22 YR
• Patient Sex: Female
• Patient Weight: 50 KG