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

Model Number	9022603AAA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that an explant procedure was performed due to the nail breaking.There was no patient harm reported.
Additional Manufacturer Narrative
Visual inspection of the returned stryde nail revealed that the housing tube was broken.Based on visual inspection, the reported failure can be confirmed.The work order was reviewed, and confirmed the device passed all inspections and acceptance tests prior to shipment.No material/manufacturing issue was found.The type of breakage observed likely resulted from a mechanical bending failure in fatigue due to excessive stress applied by the patient during daily activities.Per the precice stryde instructions for use: "the precice stryde 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." in addition, the reported nail was implanted for more than a year, which exceeds the guidelines within the ifu.The device should be removed after implantation time of no more than one year.The device history records were reviewed, and found the device was manufactured in accordance with the specified requirements and met all the required quality inspections.There were no discrepancies or non-conformances related to the reported event.
Event or Problem Description
An x-ray of the broken nail was received.

• Brand Name: PRECICE STRYDE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise, suite 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise, suite 100; aliso viejo, CA 92656 ; 9498373600
• MDR Report Key: 15262909
• Report Number: 3006179046-2022-00242
• Device Sequence Number: 12148151
• Product Code: HSB
• UDI-Device Identifier: 00887517951236
• UDI-Public: 887517951236
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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: 9022603AAA
• Device Lot Number: 9022603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 59 KG