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	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that before starting the case, they tightened the tracker clamp down with the correct tool.However, during a cori tka xr procedure, the tracker clamp slid on the tibial bone pins when cutting the femur.It is unknown which of the two were faulty.They changed to manual instrumentation for tibia cutting.There was a delay greater than 30 min.The patient care was not compromised.No other complications were reported.Surgeon was satisfied with the surgical outcome.
Additional Manufacturer Narrative
H10: internal complaint reference: case (b)(4).The cori bone pin pn rob10010, use in treatment, was not returned for evaluation.A visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be determined.While all products meet required manufacturing specifications prior to release a serial number, lot number, or part revision is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints has concluded this was an isolated event.Although the reported problem was not confirm, factors that may have contributed to the reported symptom may have been associated with mishandling.Ensure that the tracker clamp is stabilized when tightening the tracker in the clamp.Refer to cori user's manual part: inserting pins using a tracker clamp.This failure is an identified failure mode within the risk assessment.Per complaint details, there was a delay greater than 30 min.The patient care was not compromised.No other complications were reported.No operative reports are available.Surgeon was satisfied with the surgical outcome.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.If the product associated with this event is returned 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: 11515701
• Report Number: 3010266064-2021-00208
• Device Sequence Number: 4047616
• Product Code: OLO
• UDI-Device Identifier: 00885556757277
• UDI-Public: 00885556757277
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/05/2021

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: ROB10010
• Device Catalogue Number: ROB10010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 10/05/2021
• 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