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

Model Number PS11.5-80B280

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2021

Event Type  malfunction  

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 Description

Information was received that upon routine explant of the nail after the nail had successfully performed its intended treatment, it was noted the nail had signs of corrosion around the junction.There was no adverse patient impact as a result of the reported issue and the patient successfully achieved lengthening/bone consolidation.

Manufacturer Narrative

Upon return, visual inspection of the nail revealed the distraction rod of the nail had visible evidence of discoloration at the junction.The discoloration, also mentioned in the description as "corrosion" failure, is a previously known issue, which is being investigated under a capa.Visual inspection confirmed the reported discoloration failure mode.Following investigation, the nail has been quarantined.Review of the device history records indicated the precice-stryde nail was visually inspected and functionally tested prior to release.Functional testing was not applicable to the reported failure.In addition, the nail listed in this complaint was manufactured prior to the initiation of the capa.

Event Description

No additional information was provided.

• Brand Name: PRECICE STRYDE SYSTEM
• Type of Device: 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: 13087578
• MDR Text Key: 282774005
• Report Number: 3006179046-2021-00523
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517950840
• UDI-Public: 887517950840
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS11.5-80B280
• Device Lot Number: 9120209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 70 KG