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

Model Number	PS10.0-80D265
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 not been returned for evaluation.Root cause is unable to be determined at this time.
Event or Problem Description
Information was received that a revision procedure was performed on an unknown date.Per the reporter, the nail was broken.The surgeon believes it may have been due to fatigue and slow bone healing.No patient injury was reported.
Additional Manufacturer Narrative
The nail was received for visual and functional testing visual inspection confirmed the reported issue.X-ray images of the internal component revealed no anomalies.Functional testing revealed the nail was able to distract and retract with the electronic remote controller (erc) and the high-speed magnet.The nail also passed force and stroke testing.Based on the information provided, there was no particular event which could have led to the nail breaking.However, based on the type of breakage observed, it is possible that the nail broke due to the stress generated from weight bearing activities.Per the precice instructions for use (ifu), "the nail cannot withstand the stresses of full weight bearing.Patients should utilize external support and/or restrict activities as directed by the physician until consolidation occurs.

• Brand Name: PRECICE STRYDE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo 92656
• MDR Report Key: 10880737
• Report Number: 3006179046-2020-00478
• Device Sequence Number: 19556975
• Product Code: HSB
• UDI-Device Identifier: 00887517951182
• UDI-Public: 887517951182
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PS10.0-80D265
• Device Lot Number: 0011713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 02/24/2021
• 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: Hospitalization