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

Model Number	PS11.5-80SJ305
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for investigation nor were x-rays provided to confirm the alleged event.Root cause cannot be confirmed at this time.
Event or Problem Description
Information was received that during an osteotomy the nail would not lengthen.No patient injury was reported.
Additional Manufacturer Narrative
Production record review: a review of the device manufacturing records found no non-conformances or other issues related to the reported event.Device evaluation: the returned precice nail was observed and no damage was found.X-ray images revealed a broken coupler to drive stage junction at the weld.Leadscrew/coupler was completely separated from the mechanism.The nail was functionally tested and was unable to distract/retract with the erc and high-speed magnet.The nail was unable to distract/retract with the fast distractor to perform the stroke test.Due to the condition (jammed) of the nail, force testing was not performed.Attempts to obtain further event information to aid in root cause determination were made; however, no further information was provided and a root cause cannot be determined.
Event or Problem Description
See updated fields d6, d9, h3, h4, h6, h10.

• 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: 10318180
• Report Number: 3006179046-2020-00351
• Device Sequence Number: 16888766
• Product Code: HSB
• UDI-Device Identifier: 00887517951694
• UDI-Public: 887517951694
• 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,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: PS11.5-80SJ305
• Device Lot Number: 9061313AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1