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

Model Number ROB10015

Device Problem Material Fragmentation (1261)

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

Event Date 11/18/2021

Event Type  malfunction  

Event Description

It was reported that after a cori assisted surgery, it was noticed that the rubber inside the nose of the ri robotic drill attachment was peeling.It appears to be the rubber peeling and not bone.Since incident occurred after procedure, patient was not longer involved.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

D11: concomitant medical products and therapy dates.Section h3, h6: the ri robotic drill attachment, part number rob10015, s/n (b)(6), used in treatment was returned for evaluation.A relationship between the reported event and the device was established.The complaint was visually confirmed.The exterior condition shows minor wear with the drill attachment scraper visibly worn.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 concluded this was an isolated event.The most likely cause of this event is user mishandling.Care and caution should be exercised during the cleaning of the drill attachment.Per the user manual, "scrub all surfaces with a plastic bristled brush, paying particular attention to the crevices around the nose of the robotic drill attachment.Note: do not use rigid cleaning instruments near the plastic scraper in the nose." refer to the cori surgical system user's manual for proper handling.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.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: 12972402
• MDR Text Key: 284805726
• Report Number: 3010266064-2021-00858
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

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: 11/18/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 07/30/2022
• Supplement Dates FDA Received: 08/04/2022
• 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: A
• Patient Sequence Number: 1
• Treatment: CORI ROBOTICS USA, SN#: (B)(6)