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	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for investigation as it remains implanted.Root cause is unknown at this time.
Event or Problem Description
It was reported that post surgical review, the stryde femur nail was found to be retracted via x-ray.The surgeon ordered another 2 weeks of distraction and the nail was found unable to hold the distracted length.No patient injury was reported.Exchange of the nail is planned for an unknown date.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the nail lot number 90620006aaa revealed that the housing tube was broken at the second screw hole.It was reported that upon removal the nail was broken due to excessive force, however, this complaint was issued based on the nail mechanism failure.The investigation was completed based on the initial reported failure of loss of distraction.X-ray images of the internal components showed a broken anti-rotation lug and revealed the nail to be partially distracted.The reported failure of loss of distraction was confirmed with the broken lug.The nail was functionally tested with the external remote controller (erc) and high speed magnet and was able to be distracted and retracted.Based on the type of breakage observed and the information that was provided, it is possible that the anti-rotation lug broke due to stress generated from weight-bearing activities.Per the precice stryde instructions for use, the nail is not able to withstand the stress of full weight bearing and it is recommended that the user utilizes 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: 10738473
• Report Number: 3006179046-2020-00420
• Device Sequence Number: 19710484
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: 90620006AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 02/23/2021
• 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