MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO TKA RT TIBIA TWIN PEG CUT GDE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB00026
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a cori tka procedure, the bone pin got stuck in the twin peg guide.It was still used, the other pin holes were used to secure the device to cut the tibia without delays.Later, the spd tried to get it out and weren't able to.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: the navio tka rt tibia twin peg cut gde, rob00026, used for treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually confirmed.The cutting guide has a broken pin stuck in it.The most likely cause of this event is user technique.The cori user's manual provides instructions and guidelines for proper use of bone pins.Care and caution should be exercised while inserting pins.Instructions state to insert pins perpendicular to the flat surface.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints found one similar event.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.This failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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.Internal complaint reference: (b)(4) corrected data: g1 mdr reporting contact name, address and phone number.

• Brand Name: NAVIO TKA RT TIBIA TWIN PEG CUT GDE
• Common Device Name: 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; suite 100; austin, TX 78735 ; 5123913905
• MDR Report Key: 10718439
• Report Number: 3010266064-2020-01939
• Device Sequence Number: 14238174
• Product Code: OLO
• UDI-Device Identifier: 00885556684979
• UDI-Public: 00885556684979
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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: ROB00026
• Device Catalogue Number: ROB00026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORI ROBOTICS USA: ROB20000, (B)(6)
• Patient Sex: Unknown