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

Model Number	DPA1-000
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation nor were x-rays provided to confirm the alleged event.
Event or Problem Description
Information was received that the tip of precice diamond point remained within the femur when the surgeon was going to open the bone to insert the nail.The other instruments are being returned damaged from the surgery.
Additional Manufacturer Narrative
The instruments were received for visual and functional testing and the reported event was confirmed.Visual inspection revealed the thread tips of the screw capture rod (locking driver) were broken.In addition, visual inspection revealed the diamond point was broken.The root cause of the reported event is likely due to the instruments experienced high forces and/or were detached incorrectly causing the instruments to break.All instruments are functionally tested prior to shipment therefore it can be deemed the units were full functional prior to shipment.
Additional Manufacturer Narrative
Omit portugal from section e.1 on initial report.The correct country is spain.
Event or Problem Description
Correction to section e.1 (country) on initial report.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise, suite 100; aliso viejo CA 92656
• MDR Report Key: 10292066
• Report Number: 3006179046-2020-00341
• Device Sequence Number: 3376798
• Product Code: HSB
• UDI-Device Identifier: 00812258026462
• UDI-Public: 812258026462
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2021

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: DPA1-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 10/16/2020; 06/17/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 10/16/2020; 01/13/2021
• 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