MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES UNKN NAVIO ROBOTICS SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number ROB00049

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.Khan, h, et al.(2021).Blood loss and transfusion risk in robotic-assisted knee arthroplasty: a retrospective analysis.The international journal of medical robotics and computer assisted surgery (vol.17, no 6).Doi: 10.1002/rcs.2308.(b)(4).

Event Description

It was reported that on literature review "blood loss and transfusion risk in robotic-assisted knee arthroplasty: a retrospective analysis", fifty (50) patients underwent total knee arthroplasty using navio robotic system forty- nine (49) patients were implanted with genesis ii, and one (1) patient journey ii.One (1) patient experienced a blood transfusion after the ra-tka procedure using a navio robotic system.No further information is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference number: case-2022-00116697-1 sections d4 and g4 were updated.

Manufacturer Narrative

Section h10: the navio surgical system uk, part number rob00049, used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.The clinical/medical investigation concluded that without the requested medical documentation, definitive clinical factors which could have contributed to the reported event could not be concluded.Of note, blood loss with subsequent transfusion(s) is a known potential occurrence during and/or post-surgical procedures and does not support a component malperformance.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.While all products meet required manufacturing specifications prior to release a serial number, lot number, part revision or software version is required to link the device to a dhr or nc investigation.As with any surgical procedure, there is risk involved.Potential complications accompanying surgery may occur, including: allergic reaction (anaphylactic and minor), infection, mild to serious physical injury, localized static shock, delay in the operation, surgical site nerve injury, vascular injuries of the lower extremity, soft tissue damage, major bone gouging at the surgical site, bone fracture, immature implant failure, unstable knee joint, limited or restricted knee range of motion, major blunt impact injury, unintended laceration/puncture wound, and osteonecrosis.The risk review could not be completed as no sufficient information was provided that relates the specific failure mode to the device.No reasonable contributing factors could be identified based on the received complaint information and investigation results.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.Internal complaint reference number: (b)(4).

• Brand Name: UNKN NAVIO ROBOTICS SYSTEM
• 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: 15271345
• MDR Text Key: 298378872
• Report Number: 3010266064-2022-00576
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ROB00049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• 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
• Treatment: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Patient Outcome(s): Other