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

Model Number	PS10.0-65D250
Medical Device Problem Codes	Corroded (1131); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that upon explant of the nail after it had achieved intended therapeutic lengthening, it was noted the nail exhibited crevice corrosion and wear between the nail and fixation screws.Additionally, it was found that the crown of the nail had become displaced and appeared to have cold-welded to the male component instead of staying within the female component.No patient harm or adverse impact was reported.
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.
Additional Manufacturer Narrative
Device evaluation: during evaluation of the returned nail it was observed that the anti-rotation lug (crown) was disengaged from the housing tube and stuck to the distraction rod.Visual inspection also revealed that the distraction rod of the nail had crevice corrosion.The work order was reviewed and confirmed the device passed all inspections per the acceptance test and the manufacturing x-ray image showed the anti-rotation lug was seated properly in the housing body.The cause for the disengagement of the anti-rotation lug from the housing body is crevice corrosion and subsequent wear of the mating features of the anti-rotation lug and the housing tube, which loosened the assembly between the lug and the housing tube.When load was applied to the nail during patient activities, the loose assembly caused the lug to disassociate from the housing tube.A corrective action is in progress to further investigate the root cause of the crevice corrosion.Device history records review: review of the device history records (dhr) indicated the unit met all quality specifications and testing prior to release.

• Brand Name: PRECICE STRYDE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 13367897
• Report Number: 3006179046-2022-00117
• Device Sequence Number: 11760385
• Product Code: HSB
• UDI-Device Identifier: 00887517951175
• UDI-Public: 887517951175
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: PS10.0-65D250
• Device Lot Number: 9041810AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female