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

Model Number	P10.7-80V305
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/18/2024
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 during a planned removal procedure the proximal male portion of the nail remained in the patient, located in the the proximal half to proximal third of patient femur.Attempts were made to grasp the male section including the gearbox with various long pituitary forceps unsuccessfully.This portion of the nail remains in the patient with a secondary procedure expected.
Additional Manufacturer Narrative
The device was not returned for evaluation as a portion of the nail remained in-situ.Review of the provided x-rays visually confirmed that the distraction rod was still in the patient along with the lead screw, anti-jam washer, locking pin and coupler.The cause of the reported event is unable to be determined; however, it is believed that nail dissociates during removal due to internal retention mechanism failure.Devie history review (dhr): a review of the dhr documents indicates the device was manufactured by the specified requirement at the time and met all the required inspections upon release to finished goods.
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, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise suite 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise suite 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 19073809
• Report Number: 3006179046-2024-00123
• Device Sequence Number: 4658476
• Product Code: HSB
• UDI-Device Identifier: 00887517934871
• UDI-Public: 887517934871
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/18/2024

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: P10.7-80V305
• Device Lot Number: 8051204BAB
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2018
• 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: Prefer Not To Disclose