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

Model Number	P8.5-50N150
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a little over a year after implantation a revision procedure was performed due to the nail not lengthening.The nail has been explanted and a replaced with another nail.
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
No additional information has been provided.
Additional Manufacturer Narrative
Additional data: b5, d9, h3, h6, h10 device evaluation: upon receipt of the device, a visual inspection reflected a scratch that removed the anodized coating near the part number markings.This scratch extends around to the lot number side of the nail.Additionally, a burr has been observed on one end of the nail through the hole on the distraction rod along with residual tissue in the distraction rod grooves.Device x-rays revealed that the locking pin failed and separated the distraction rod from the gear train.Functional testing was unable to be performed due to the broken pin.The device pistons when pressure is applied.Although the root cause is unable to be definitively determined, the broken locking pin could have resulted from the removal process.It should also be noted that the recommended implantation time of 365 days was exceeded, increasing the likelihood of a difficult removal resulting in the locking pin fracturing.Device labeling: per the precice instructions for use (ifu), "the device should be removed after implantation time of no more than one year".Device record review: a review of the device history record (dhr) indicates the device was manufactured to the specified requirements at the time and met all of the required inspections before shipment.

• 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: 17921816
• Report Number: 3006179046-2023-00345
• Device Sequence Number: 19578865
• Product Code: HSB
• UDI-Device Identifier: 00812258028251
• UDI-Public: 812258028251
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/20/2023

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: P8.5-50N150
• Device Lot Number: 2011705AAA
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• 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: 11 YR
• Patient Sex: Female
• Patient Weight: 42 KG