MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10015

Device Problem Break (1069)

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

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, during a cori assisted tka surgery, the surgeon was burring his tibial twin peg holes, he removed the real intelligence robotic drill guard without issue.When he went to put the guard back on, the suction attachment broke off outside the patient; therefore, no broken pieces fell inside the patient.The procedure was finished with a smith and nephew back up device without delay.The patient was not harmed beyond the reported problem.Additionally, when assembling the trays after the case and after cleaning, it was noticed that the white plastic inside the ri robotic drill attachment (the wiper) was broken.

Manufacturer Narrative

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

Event Description

It was reported that, during a cori assisted tka surgery, the surgeon was burring his tibial twin peg holes, he removed the real intelligence robotic drill guard without issue.When he went to put the guard back on, the suction attachment broke off outside the patient; therefore, no broken pieces fell inside the patient.The procedure was finished with a smith and nephew back up device without delay.The patient was not harmed beyond the reported problem.Additionally, when assembling the trays after the case and after cleaning, it was noticed that the white plastic inside the ri robotic drill attachment (the wiper) was broken.

Manufacturer Narrative

H3, h6: the ri robotic drill attachment (us), rob10015, (b)(6) intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually confirmed.The wiper is completely missing from the distal end of the drill attachment.A functional evaluation was not required as the reported problem was confirmed visually.The most likely cause of this event is product mishandling.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 review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint this case.Refer to the cori surgical system user¿s manual for proper handling.Care and caution should be exercised during the surgical site setup, surgery and tear down to protect the device from an unforeseen force, such as falling onto a hard surface or damage.Refer to cori cleaning and sterilization care for proper handling during the cleaning and decontamination process to not damage or remove wiper from the distal end of the drill attachment.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.

• Brand Name: RI ROBOTIC DRILL ATTACHMENT
• 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: 13295254
• MDR Text Key: 285761240
• Report Number: 3010266064-2022-00044
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757345
• UDI-Public: 00885556757345
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: ROB10015
• Device Catalogue Number: ROB10015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/19/2022
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 04/06/2022
• 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: ROB20000-CORI ROBOTICS USA