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

Model Number	P10.7-80B275
Medical Device Problem Codes	Failure to Advance (2524); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause of the failure to distract 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 nail was not opening and a revision procedure had to be performed.The patient used a wheelchair to ambulate and has no history of trauma or accidents.During the revision procedure, the surgeon attempted to increase the osteotomy with the nail still placed in the medullary canal, causing internal damage by the osteotome to the nail causing it to move freely.The nail was replaced and the procedure was completed.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: the nail was returned for evaluation.A visual inspection revealed several deep scratches on the housing tube.Additionally, the device was found to exhibit pistoning, a free movement of the distraction rod, indicating an internal mechanical failure.The provided x-rays from the complaint were also reviewed.Although the image from the first x-ray dark, it does appear that the gap between the distraction rod and the coupler is significantly smaller than the gap shown in the second x-ray.This would indicate that it is possible that the nail was over-retracted.In-house device x-ray analysis confirmed the internal failure by identifying significant empty space within the device, attributed to the disconnection of the gear train and magnet.This internal separation was caused by the assembly pulling away from the grooves in the housing tube, leading to the internal components becoming disjointed.The device was then sectioned to review the internal components.Due to this separation, functional testing was unable to be performed.A visual inspection was conducted on the section of the housing tube where the grooves are featured.It was discovered that the grooves had been completely stripped as the inside of the housing tube was shiny from the removed anodization.Based on these findings, the failure to distract cannot be confirmed because the device was returned in a non-operational state.It is possible that the implant was over-retracted based on the x-rays provided and upon removal of the implant, excessive force was required to cause the distraction rod coupler to come off free from the housing grooves.However, it is not known what caused the excessive force required to disjoint the implant.

• 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: 18566217
• Report Number: 3006179046-2024-00103
• Device Sequence Number: 6595307
• Product Code: HSB
• UDI-Device Identifier: 00812258020262
• UDI-Public: 812258020262
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 03/12/2024

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: P10.7-80B275
• Device Lot Number: 2090121AAA
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 52 KG