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

Model Number	PS10.0-50D235
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/09/2021
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 during removal the proximal part of the nail broke when the surgeon unlocked the end cap and the distal part of the nail was unable to be removed.A second procedure was required to explant successfully.
Event or Problem Description
No additional information provided.
Additional Manufacturer Narrative
The nail was received for visual and functional testing.Examining the broken nail closely revealed that the location where it broke was where there are holes on either side of the nail to insert screws.Also, the way the nail is broken, the broken ends are not straight but rather stretched.This could indicate the nail was subjected to excessive bending, rendering it softer and resulting in its breakage at this location.The location of the failure (at the two holes on either sides of the nail) is consistent with what we would expect from a mechanical bending failure in fatigue.Functional testing was not applicable due to the status of the nail.A device history review (dhr) was performed on lot number 9040401 and there were no deviations in the manufacturing process and the finished product met all acceptance criteria prior to shipment.Complaint failure mode broken nail has no change orders (co) or capas.

• 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: 12331580
• Report Number: 3006179046-2021-00447
• Device Sequence Number: 4425192
• Product Code: PGN
• UDI-Device Identifier: 00887517951168
• UDI-Public: 887517951168
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: PS10.0-50D235
• Device Lot Number: 9040401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 70