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

Model Number	P12.5-80X305
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and is pending evaluation.The root cause is unable to be determined at this time.A supplemental report will be submitted upon completion of device evaluation.
Event or Problem Description
Information was received that the nail is broken.No patient harm was reported.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned unit confirmed the reported failure.The work order was reviewed and confirmed the device passed all inspections and acceptance tests.The nail has been determined to have met manufacturing specifications during assembly.The breakage was not determined to have been related to the manufacturing processes or material failure.It is possible/likely that the device was already fractured prior to removal.The location of the failure is consistent with what we would expect from a mechanical bending failure in fatigue.Device records review: review of the device history record for the nail confirmed that it met all of the required quality inspections.

• 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: 12269211
• Report Number: 3006179046-2021-00425
• Device Sequence Number: 4255270
• Product Code: HSB
• UDI-Device Identifier: 00887517935663
• UDI-Public: 887517935663
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: P12.5-80X305
• Device Lot Number: 0091901AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1