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

Model Number	P10.7-80D365
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/19/2023
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 surgeon was implanting the nail and upon testing the nail with the external remote controller (erc) the nail was not responding with normal distraction.The nail was removed and tested on the back table with a fast distractor, but it was still unresponsive.The procedure was completed using a new nail.
Additional Manufacturer Narrative
The returned nail was visually inspected and there was no visible outside damage observed.An x-ray of the internal components revealed that the end keeper was no longer properly positioned inside the housing tube.It was also observed that both the bearing and end keeper were broken with visible fragments.Functional testing was performed and no distraction force could be measured, confirming that the device was jammed.It is possible that the friction encountered between the magnet and the broken bearing jammed the internal actuator mechanism during insertion but this cannot be confirmed.Device record review: a review of the dhr indicated that the unit all met all required inspections and specifications prior to release.
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, 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: 16897465
• Report Number: 3006179046-2023-00194
• Device Sequence Number: 17723647
• Product Code: HSB
• UDI-Device Identifier: 00812258020682
• UDI-Public: 812258020682
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: P10.7-80D365
• Device Lot Number: 0070604BAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2020
• 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: 16 YR
• Patient Sex: Male
• Patient Weight: 64 KG