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

Model Number	PS13.0-80B335
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and the evaluation is pending.The root cause is unable to be determined at this time.A supplemental report will be provided when the evaluation has been completed.
Event or Problem Description
Information was received that during explant the nail came apart.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Device evaluation: the returned precice stryde device was observed and the anti-rotation lug was disengaged from the housing tube which confirmed the reported failure mode.The barbs of the anti-rotation lug had minor damage, likely from the disengagement which occurred during the removal of the device.Functional testing and x-ray did not apply due to the nail condition (it was not fully assembled).In addition, all device components were removed from the patient during implant removal and sent to nso for investigation.Device history review: the work order was reviewed and confirmed the device passed all inspections per the acceptance tests at0070 rev-b and at0068 rev-c.The manufacturing x-ray image showed the anti-rotation lug (crown) was seated properly in the housing body.In addition, the device was properly manufactured and inspected per the work order for lot#: 9060507.

• 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: 11886455
• Report Number: 3006179046-2021-00280
• Device Sequence Number: 17253185
• Product Code: HSB
• UDI-Device Identifier: 00887517950932
• UDI-Public: 887517950932
• 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 Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: PS13.0-80B335
• Device Lot Number: 9060507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR