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

Model Number ROB10015

Device Problems Detachment of Device or Device Component (2907); Mechanical Jam (2983); Unintended Movement (3026); Noise, Audible (3273)

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

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, during set up of cori assisted surgery, the ri robotic drill attachment made a rattling sound when shaking it due to the movement of its internal parts.Procedure was performed, without any delay, with a s+n back-up device.There was no patient involvement.

Manufacturer Narrative

H3, h6: the cori drill long attachment, p/n rob10015, sn (b)(6), intended for used in treatment, was returned for evaluation.A relationship between the reported event and the device was established visually.The long attachment retaining nut was out torque specifications and one of the bearings look wear.The most likely cause of this event is the retaining nut became loose due to vibration.This can cause the long attachment become stuck in the drill.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 has identified prior events.A historical escalation event review was completed.The review determined that prior escalation actions are applicable to the scope of this complaint and further investigation into the reported failure is being conducted to determine if additional escalation actions are required.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Further investigation into the reported failure is being conducted to determine if additional actions are required.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

Manufacturer Narrative

H3, h6: the cori drill long attachment, p/n rob10015, sn (b)(6), intended for used in treatment, was returned for evaluation.A relationship between the reported event and the device was established visually.The long attachment retaining nut was out torque specifications and one of the bearings look wear.The most likely cause of this event is associated with a loose drill attachment retaining nut.This can cause the long attachment become stuck in the drill.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 has identified prior events.A historical escalation event review was completed.The review determined that prior escalation actions are applicable to the part number or serial number and scope of this complaint, and no further escalation action is required.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.As part of corrective actions, continuous improvements have been made to the assembly process.The assembly work instruction has been updated to include the application of a thread-lock compound to the drill attachment retaining nut during assembly.The failure mode will continue to be monitored through complaint investigation and trended through post market surveillance activities.After further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.It was determined that the issue does not meet the criteria to be reportable, since the risk for the relevant failure mode is low, and that no further actions are needed for current inventory or product in the field.Event may result in a short procedural delay and/or require use of a backup device to continue procedure.Moreover, if the device malfunction were to recur, it would not be likely to cause or contribute to a death or serious injury and, therefore, is considered not reportable pursuant to applicable regulations.

• 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: 14132109
• MDR Text Key: 289429241
• Report Number: 3010266064-2022-00293
• 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,Followup
• Report Date: 05/13/2024

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: 03/22/2022
• Initial Date FDA Received: 04/17/2022
• Supplement Dates Manufacturer Received: 06/12/2022; 05/07/2024
• Supplement Dates FDA Received: 06/14/2022; 05/13/2024
• 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
• Treatment: ROB20000