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

Model Number	ROB00025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cori assisted tka surgery, the pin got stuck in the navio tka left tibia twin peg cut guide.They were able to get the pin out, but could not get another pin to pass through.Therefore, they used a different pin hole to on the block.The procedure was completed, without delay, using the same device.Patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the navio tka left tibia twin peg cut guide, part number rob00025, lot number (10)52669, used for treatment was not returned for evaluation.An image was provided.A relationship between the reported event and the device could not be established.The clinical/medical investigation concluded that based on the information provided, the root cause of the reported events cannot be definitively concluded.Per case details, ¿the patient was not harmed beyond the reported¿ use of a different hole used on the cutting block and no injury is alleged.Additionally, there was no reported surgical delay.The patient impact was the use of the additional pin hole needed to complete the procedure.No further patient impact can be determined and no further clinical medical assessment is warranted.The reported problem could not be confirmed with a visual inspection.The image provided did not confirm the pins were stuck on the device.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.Refer to the surgical technique guide for knee arthroplasty (500197 rev c) page 37, section preparing the bone in tka, preparing the tibia which describes the installation and insertion of speed pins to install.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with an improper insertion of the pins.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
Additional Manufacturer Narrative
The (b)(6).Tka left tibia twin peg cut guide, part number rob00025, lot number (10)52669, used for treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.A pin could not be inserted into an existing pin hole.An image was provided.A visual inspection of the image provided did not confirm the pin was stuck in the device.The most likely cause of this event is due to damaged internal surface due to prior stuck pin.A review of manufacturing records indicate the device met all specifications upon release into distribution.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.Refer to the surgical technique guide for knee arthroplasty, section preparing the bone in tka, preparing the tibia which describes the installation and insertion of speed pins to install.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.The clinical/medical investigation concluded that based on the information provided, the root cause of the reported events cannot be definitively concluded.Per case details, ¿the patient was not harmed beyond the reported¿ use of a different hole used on the cutting block and no injury is alleged.Additionally, there was no reported surgical delay.The patient impact was the use of the additional pin hole needed to complete the procedure.No further patient impact can be determined and no further clinical medical assessment is warranted.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: NAVIO TKA LEFT TIBIA TWIN PEG CUT GUIDE
• 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 12844206
• Report Number: 3010266064-2021-00784
• Device Sequence Number: 19985789
• Product Code: OLO
• UDI-Device Identifier: 00885556684917
• UDI-Public: 00885556684917
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2022

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: ROB00025
• Device Catalogue Number: ROB00025
• Device Lot Number: (10)52669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 10/09/2022; 12/08/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 10/11/2022; 12/12/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown