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

Model Number	P10.7-80B245
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
It was reported that the nail did not extend after the implant procedure.The nail was removed and replaced with a new 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
Additional information has been provided.
Additional Manufacturer Narrative
Additional data: b5, b6, d9, h3, h6, h10 device evaluation: visual inspection of the returned nail was conducted and it was observed that the nail had a fine scratch on the housing body and distraction rod.The device was functionally tested and was able to be distracted, therefore, the reported failure was unable to be confirmed.Although the complaint is unable to be confirmed, x-rays were taken of the nail and the aluminum bronze nut was found to be backed out of the distraction rod.If the bond fails and the distraction nut backs out from the distraction rod, that could potentially lead to a device failing to distract.A corrective and preventive action (capa) was initiated to address the bond failure of the distraction nut, however, this nail was built prior to the implementation of the capa.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.

• 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: 17817556
• Report Number: 3006179046-2023-00310
• Device Sequence Number: 6124643
• Product Code: HSB
• UDI-Device Identifier: 00812258020255
• UDI-Public: 812258020255
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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: P10.7-80B245
• Device Lot Number: 2083102AAA
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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
• Patient Weight: 68 KG