MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI BONE PINS 4 MM X 127 MM QTY: 4; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after completing the cori ukr procedure, it was found that the tip of the bone pin was broken off.The patient was not harmed during the procedure.Cori was used for the entire procedure.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: the ri bone pin, part rob10010 used for treatment was not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed.While all products meet required manufacturing specifications prior to release, a serial number is required to complete a manufacturing dhr review.A complaint history review for similar reported/confirmed complaints has identified no prior events.Although the reported problem was not confirmed, a contributing factor may be component damage.No containment or corrective actions are recommended at this time.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: RI BONE PINS 4 MM X 127 MM QTY: 4
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10655708
• Report Number: 3010266064-2020-01835
• Device Sequence Number: 3564401
• Product Code: OLO
• UDI-Device Identifier: 00885556757277
• UDI-Public: 00885556757277
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: ROB10010
• Device Catalogue Number: ROB10010
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 07/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1