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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and is pending evaluation.The root cause cannot be confirmed at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the nail did not lengthen intra-operatively during external remote controller (erc) testing at the end of the procedure.The nail was removed and tested on the back table with no change.The procedure was completed using a new nail.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: initial visual inspection of the returned nail reflected a deep cut on the distraction rod exposing bare metal.The in-house x-ray was not able to determine any mechanical disparities that would prevent the device from functioning as intended.Functional testing was performed and the device performed as expected; the device was able to be retracted and distracted and passed force testing.It was noted that the device was very warm to the touch after testing was completed.It was also noted that the nail would distract very slowly when using the fast distractor.The device was then sectioned using a lathe and a visual inspection of the internal components was conducted.It was observed that the gear train was not properly lubricated.Based on the investigation, the reported failure to distract was unable to be confirmed as the nail passed all production acceptance tests.There was an alternative observation that the nail distracted slowly and would warm up after long periods of distraction.Upon sectioning the nail, it was found that the nail had insufficient amounts of lubrication.Device record review: a review of the device history record (dhr) indicates the device was manufactured by the specified requirement at the time and met all of the required inspections prior to 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: 17921711
• Report Number: 3006179046-2023-00344
• Device Sequence Number: 6795398
• Product Code: HSB
• UDI-Device Identifier: 00812258020279
• UDI-Public: 812258020279
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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: P10.7-80B305
• Device Lot Number: 2052617AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• 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: 05/26/2022
• 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 Sex: Male