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

Model Number	PS13.0-80B280
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
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 (b)(6) 2020.It was reported that during a follow up appointment they noticed that the nail did not lengthen.No patient injury was reported.
Event or Problem Description
No additional event information was provided.
Additional Manufacturer Narrative
The customer¿s report that the nail did not lengthen was confirmed.Visual inspection showed no visible damage on the nail and it was partially distracted.However, x-ray images of internal components revealed a broken radial bearing.The nail was functionally tested and was unable to distract and retract with the erc and high-speed magnet.Upon dismantling the device, corrosion on the radial bearing was visible.Review of manufacturing records found there were no non-conformances, deviations, or other issues related to the reported event.Inspection data for the lot¿s radial bearing was reviewed and confirmed the part passed all quality inspections.The manufacturing x-ray image showed the radial bearing was seated properly in the housing body.The root cause for the broken radial bearing cannot be identified.

• 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 CA 92656
• MDR Report Key: 10849229
• Report Number: 3006179046-2020-00437
• Device Sequence Number: 14282110
• Product Code: HSB
• UDI-Device Identifier: 00887517950918
• UDI-Public: 887517950918
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 03/25/2021

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 Expiration Date: 03/31/2022
• Device Model Number: PS13.0-80B280
• Device Lot Number: 0040105AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/17/2020
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 03/25/2021
• 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
• Patient Age: 28 YR
• Patient Weight: 91