MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CORI; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10024

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

Patient Problems Loss of Range of Motion (2032); Fibrosis (3167)

Event Date 05/06/2022

Event Type  Injury  

Event Description

It was reported that, after a cori assisted tka surgery had been performed on 17-mar- 2022, the patient had a range of motion of 80 degrees and it was not improving with therapy.The patient will undergo a manipulation under anesthesia on 10-may-2022 to treat this adverse event.The patient is recovering.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Section h3, h6: the real intelligence cori, part number rob10024, serial number (b)(6) 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 the crfs document the ae(#1) as severe and anticipated, definitely related to the procedure but unrelated to the system/instrumentation with an aware date of (b)(6) 2022 (6 weeks follow up) with leg alignment/standing long leg x-ray report of 5 degree varus and patient is ¿:recovering /resolving¿.Although the root cause of the reported event cannot be determined based on the crfs provided, arthrofibrosis is a known post-surgical occurrence and it cannot be concluded that there is any malperformance of the implants.The patient impact beyond the reported limited rom/arthrofibrosis (ae#1) and subsequent mua cannot be determined.No further medical assessment can be rendered at this time.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.Cori is a surgical tool designed to provide assistance to the surgeon; it is not a substitute for the surgeon¿s experience and skill.The surgeon is responsible for implant planning and the conduct of the surgery during which cori is being used.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.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.H6: health effect - impact cod.

Manufacturer Narrative

H3, h6: the real intelligence cori, part number rob10024, (b)(6), intended for use in treatment was returned for evaluation.A relationship between the reported event and the device could not be established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed, and the reported problem was not confirmed, the cori console functioned as intended.A kpc test, case, and calibration were all completed without error.The software files were downloaded from the device and provided for investigation.The log files do not indicate any system or software issue related to the reported complaint.The screenshots were reviewed with clinical account representatives and the reported complaint could not be confirmed.No definitive conclusions could be drawn from the plan, as there did not appear to be any abnormalities.Although the reported problem was not confirmed through a visual or functional evaluation, it was noted that the surgeon could have planned for a looser gap when the knee was in extension and could be a possible contributing factor in the reported arthrofibrosis.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.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.Cori is a surgical tool designed to provide assistance to the surgeon; it is not a substitute for the surgeon¿s experience and skill.The surgeon is responsible for implant planning and the conduct of the surgery during which cori is being used.The risk review could not be completed as insufficient information was provided that relates the specific failure mode to the device.Per complaint details, a manipulation under anesthesia (mua) was required due to the onset of a serious adverse event (ae#1) left knee arthrofibrosis within 2 months post discharge of the cori-assisted left tka with patella resurfacing.Reportedly, the patient had a range of motion of 80-degrees and it was not improving with therapy.The crfs document the ae(#1) as severe and anticipated, definitely related to the procedure but unrelated to the system/instrumentation with an aware date of 06-may-2022 (6 weeks follow up) with leg alignment/standing long leg x-ray report of 5 degree varus and patient is ¿:recovering /resolving¿.Although the root cause of the reported event cannot be determined based on the crfs provided, arthrofibrosis is a known post-surgical occurrence and it cannot be concluded that there is any malperformance of the implants.The patient impact beyond the reported limited rom/arthrofibrosis (ae#1) and subsequent mua cannot be determined.No further medical assessment can be rendered at this time.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored through complaint investigation and post market surveillance activities.

• Brand Name: REAL INTELLIGENCE CORI
• 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: 14545156
• MDR Text Key: 292957027
• Report Number: 3010266064-2022-00416
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2022

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 Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/30/2022
• Supplement Dates Manufacturer Received: 08/01/2022; 11/14/2022
• Supplement Dates FDA Received: 08/06/2022; 11/16/2022
• 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: JOURNEY TIBIA BASE NP LT SZ 6, LOT#: 21HM11952; JRNY BCS PAT RESRF RD 35 MM STD, LOT#: 21JM05301; JRNY II CR FEM COCR NP LT SZ 6, LOT#: B2124620; JRNY II CR ISRT XLPE LT SZ 5-6 10MM, LOT# 19EM13116
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 101 KG