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

Model Number	P10.7-80B305
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned, however, it is pending 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 15 days after the implant procedure, the surgeon noticed that the nail had distracted very little and decided that the distraction of the nail should be accelerated; however, after follow up, it was noticed that distraction had completely stopped.It was then decided that the patient should have another procedure where the osteotomy line was checked and 1cm lengthening was attempted and was unsuccessful.The nail was then explanted, lengthening was attempted in the operating room again and was successful.The nail was was then implanted again into the patient, however, the nail would not distract.It was finally decided that they would implant a new nail.
Additional Manufacturer Narrative
Device evaluation: the nail was returned to nuvasive for evaluation.An initial visual inspection discovered minor scratches to the housing tube and minor burrs generated from the drilling process on the distraction rod holes.Force testing was performed and a minimum retraction, maximum distraction, and force testing all met the specifications.X-rays showed no damage of the internal components.The nail performed as expected, therefore, the reported failure was unable to be confirmed and no root cause was able to be determined.Device record review: a review of the device history record (dhr) indicates the nail was manufactured by the specified requirement at the time and met all the required inspections before shipment.
Event or Problem Description
No additional information has been provided.

• Brand Name: PRECICE 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: 17646958
• Report Number: 3006179046-2023-00332
• Device Sequence Number: 5633346
• Product Code: HSB
• UDI-Device Identifier: 00812258020279
• UDI-Public: 812258020279
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K220234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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: P10.7-80B305
• Device Lot Number: 3050317AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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 Age: 19 YR
• Patient Sex: Male
• Patient Weight: 68 KG