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

Model Number	BT10-90X340-7
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the patient presented with pain in the knee.X-ray examination reportedly revealed the implant was fractured.Per the reporter, the patient did not regularly attend the scheduled x-ray examinations to check, therefore, the docking site and pseudoatrhrosis could not be checked by the physician for a long time.The patient denied having had any falls.A revision procedure was performed and the nail was explanted.The patient was reported to have been full weight bearing beyond the instructions for use (ifu).No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: the device was returned to the manufacturer for evaluation.Visual inspection was completed and it was observed that the device was broken in two pieces.In-house x-rays revealed that the gear train and distraction rod were intact and there was no observable damage to the internal components.Functional testing was unable to be performed due to the device being broken in two pieces.A root cause of the break is unable to be determined, however, based off the information provided by the surgeon the patient failed to follow the guidelines in the instructions for use (ifu).The patient had poor bone density due to smoking, coupled with missed follow-up appointments, and full weight bearing beyond instructions.It is likely that the cause of the break was due to material fatigue in the area of the transportation routes due to increased torsional forces.Instructions for use: "patients unwilling or incapable of following postoperative care instructions." "patients with conditions that tend to retard healing such as blood supply limitations, peripheral vascular disease or evidence of inadequate vascularity." "the precice 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.".
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, 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: 18880613
• Report Number: 3006179046-2024-00117
• Device Sequence Number: 9256031
• Product Code: HSB
• UDI-Device Identifier: 00887517979742
• UDI-Public: 887517979742
• 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: 2023
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 06/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: BT10-90X340-7
• Device Lot Number: 3070626AAA
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 50 KG