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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: case-(b)(4).
Event or Problem Description
It was reported that during cori tka procedure when removing 1 of the 2 cori bone pins from the femur, the surgeon noticed that the tip of the bone pin had broken off.The patient was not harmed.The tip of bone pin was disposed of in sharps.No delay or additional complications were reported.
Additional Manufacturer Narrative
H3, h6: the cori bone pin pn rob10011,used in treatment, was returned for evaluation.A relationship between the reported event and the device was established.It was visually confirmed the reported problem.The tip was detached of the bone pin.A functional evaluation was not performed.Product history review was not performed for this event, due to be unable of obtain the lot number.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause that may have contributed to the reported symptom may be associated with mishandling.Care and caution should be exercised during the surgical site setup and tear down to protect the pin from an unforeseen force, such as falling onto a hard surface or damage during transport.Refer to the cori surgical system user's manual and the cori surgical system instrument kit cleaning and sterilization guide for proper handling.This failure is an identified failure mode within the risk assessment.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 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: 11483517
• Report Number: 3010266064-2021-00190
• Device Sequence Number: 19652314
• Product Code: OLO
• UDI-Device Identifier: 00885556757307
• UDI-Public: 00885556757307
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K201022
• 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): 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention