MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI BONE PINS 4 MM X 152 MM QTY: 2; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10011
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a cori tka procedure, there was a bent bone pin 4.0 mm 152 mm.There was a delay of fewer than 30 minutes.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: the ri bone pin, part rob10011 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 152 MM QTY: 2
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 11229656
• Report Number: 3010266064-2021-00057
• Device Sequence Number: 17169701
• Product Code: OLO
• UDI-Device Identifier: 00885556757307
• UDI-Public: 00885556757307
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: ROB10011
• Device Catalogue Number: ROB10011
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1