MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM TR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number NPFS02080

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Impaired Healing (2378); Fluid Discharge (2686)

Event Date 11/25/2022

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4) h10: this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.Turan, k., camurcu, y., kezer, m.Et al.Preliminary outcomes of kinematically aligned robot-assisted total knee arthroplasty with patient-specific cartilage thickness measurement.J robotic surg 17, 979¿985 (2023).(b)(6).

Event Description

It was reported that on literature review "preliminary outcomes of kinematically aligned robot-assisted total knee arthroplasty with patient-specific cartilage thickness measurement", after three (3) tka procedures assisted with navio system, patients had prolonged wound drainage and healing.In these patients, low-molecular-weight heparin was stopped (prophylaxis continued with acetylsalicylic acid) and an antibiotic treatment was started.Patients¿ outcome is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference number: (b)(4).

• Brand Name: NAVIO SURGICAL SYSTEM TR
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18187175
• MDR Text Key: 328716359
• Report Number: 3010266064-2023-00206
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556633052
• UDI-Public: 885556633052
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K152574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other