MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM; FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY

Model Number	EAD-P3-010
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation nor were x-rays or ultrasound images provided to confirm the alleged event.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that the electronic remote controller (erc) was lengthening at double the speed it was originally programmed for.Patient experienced pain but no harm was reported.
Event or Problem Description
Report updated to include investigation findings.
Additional Manufacturer Narrative
Device evaluation: the unit was powered on successfully.Functional testing revealed the device ran successfully.Internal component inspection was performed and there we no discrepancies.A review of the device's physician history menu indicated that the unit was operated for more than one week than that which was claimed to be and the failure mode was not confirmed as the unit functioned as intended.A device history record was reviewed and no discrepancies were found as the device was manufactured in accordance with specified requirements and met all of the required quality inspections.

• Brand Name: PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Common Device Name: FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9612727
• Report Number: 3006179046-2020-00102
• Device Sequence Number: 2677441
• Product Code: HSB
• UDI-Device Identifier: 00887517001344
• UDI-Public: 887517001344
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K173129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: EAD-P3-010
• Device Lot Number: 8122608BAB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other