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

Model Number	P8.5-50C230
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for investigation pictures provided confirm the alleged event.Root cause is unknown at this time.
Event or Problem Description
Information was received that the telescoping rod detached from the main nail during removal.No patient injury was reported.
Additional Manufacturer Narrative
Visual inspection of the returned products confirmed that the nail was broken.X-ray images and visual inspection of the internal components showed failures in two areas, breakages at the weld between the coupler and the lead screw drive stage and (2) at the housing tube, and anti-rotation lug junction.The root cause of the breakage appears to be forces applied during the removal process.A review of the dhr confirmed no ncmrs/ deviations associated with the work order and that the finished device met all required quality inspections (acceptance testing and x-ray inspection) prior to release.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 10377339
• Report Number: 3006179046-2020-00372
• Device Sequence Number: 2800841
• Product Code: HSB
• UDI-Device Identifier: 00812258020392
• UDI-Public: 812258020392
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: P8.5-50C230
• Device Lot Number: A140625-44
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/12/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR