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

Model Number	P10.7-80B245
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation nor were x-rays provided to confirm the alleged event.Root cause cannot be determined at this time.The reported event has been addressed in the device labeling.Device has not been returned.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter, after attaching the precice nail onto the locking rod through the drill guide arm the scrub nurse tested the alignment of the 5mm drill inside the drill bushing and drill guide and the 5mm drill was not able to go through the screw holes of the nail.This test was done on both screw holes of the nail.The scrub nurse then undid the assembly and nail.The nail was again attached to the locking rod with guide arm and the process was completed again yielding the same result.The drill could not go through the screw holes.The surgeon then attempted this process also with the same result.The nail was used in the patient without drilling through the guides.The surgeon was able to use the same screw holes.The surgeon commented that the alignment was out about 3mm which was possibly the result of a bent drill guide arm or screw holes milled slightly out.

• 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: 11115027
• Report Number: 3006179046-2021-00101
• Device Sequence Number: 19844138
• Product Code: HSB
• UDI-Device Identifier: 00812258020255
• UDI-Public: 812258020255
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2021

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: 0073008AAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1