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

Model Number	PS10.0-80B265
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/12/2020
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.The reported event has been addressed in the device labeling.Device has not been returned.
Event or Problem Description
Information was received that a revision procedure was performed on an (b)(6) 2020.As per the reporter, the nail is broken.No patient injury was reported.
Event or Problem Description
No additional event information has been provided.
Additional Manufacturer Narrative
Additional information: d9, h3, h4, h6, h10.Correction: d4 (lot number).Production record review: the device history record was reviewed and found no deviations, non-conformances, or other issues related to the reported event.The nail met all inspection, specification, and release criteria.Device evaluation findings: visual inspection of the returned product found the nail was fractured.Functional testing could not be performed due to the condition of the nail.The nail thickness at the broken region was measured and found to meet specifications.Based on reported information, no event in particular was reported to have occurred which could have led to the nail breaking.However, based on the type of breakage observed, it is probable that the nail broke due to stress generated from weight bearing activities.Device labeling review: per the precice stryde instructions, ¿.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.".

• 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: 11228123
• Report Number: 3006179046-2021-00111
• Device Sequence Number: 17169710
• Product Code: HSB
• UDI-Device Identifier: 00887517950765
• UDI-Public: 887517950765
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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: PS10.0-80B265
• Device Lot Number: 9021311AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 03/30/2021
• 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 Weight: 50