MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE TRACKER ARRAY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSR120010
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up for a navio assisted ukr, they were calibrating the handpiece, and both the handpiece test and drill test were ran prior to calibration and passed.When entering the handpiece calibration stage of the software, the camera could not see the navio handpiece tracker array in view.It was able to see the probe, but not the handpiece.They re-checked the handpiece assembly and everything checked out as properly assembled.They made sure once again that all of the flat markers were flush, but the camera was still unable see the handpiece array.Then, they replaced the flat markers on the handpiece array and the camera was still not seeing the handpiece array.During this time, an error popped up on the screen stating "handpiece error".They checked the cables, unplugged and replugged and hit dismiss.The error did not pop up again (b)(4).Then, they tried calibrating again, but the camera was still not seeing the handpiece array.They visibly looked at the handpiece array and it appeared that it may be bent.They got a new handpiece array and assembled it onto the handpiece.The camera was then able to see both the handpiece array and the probe.Then, they successfully calibrated and homed the handpiece and were able to start the case.However, the surgeon was doing a ukr vs.Tka and intra-operatively decided to do a tka.Since the surgeon does not use the robot for his tkas, the robot was no longer used for the case and the procedure was completed with manual instrumentation due to the surgeon preference without significant delays.The patient was not harmed due to the reported problem.After the case, they took the array and laid it on a flat surface and it appeared that it was bent.It rocked on the surface and it was uneven on its points of contact to the flat surface.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during set up for a navio assisted ukr, they were calibrating the handpiece, and both the handpiece test and drill test were ran prior to calibration and passed.When entering the handpiece calibration stage of the software, the camera could not see the navio handpiece tracker array in view.It was able to see the probe, but not the handpiece.They re-checked the handpiece assembly and everything checked out as properly assembled.They made sure once again that all of the flat markers were flush, but the camera was still unable see the handpiece array.Then, they replaced the flat markers on the handpiece array and the camera was still not seeing the handpiece array.During this time, an error popped up on the screen stating "handpiece error".They checked the cables, unplugged and replugged and hit dismiss.The error did not pop up again (b)(4).Then, they tried calibrating again, but the camera was still not seeing the handpiece array.They visibly looked at the handpiece array and it appeared that it may be bent.They got a new handpiece array and assembled it onto the handpiece.The camera was then able to see both the handpiece array and the probe.Then, they successfully calibrated and homed the handpiece and were able to start the case.However, the surgeon was doing a ukr vs.Tka and intra-operatively decided to do a tka.Since the surgeon does not use the robot for his tkas, the robot was no longer used for the case and the procedure was completed with manual instrumentation due to the surgeon preference without significant delays.The patient was not harmed due to the reported problem.After the case, they took the array and laid it on a flat surface and it appeared that it was bent.It rocked on the surface and it was uneven on its points of contact to the flat surface.
Additional Manufacturer Narrative
H3, h6: the navio tracker array, pn pfsr120010, used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported event was confirmed visually.The device showed moderated exterior condition and it was found to be significant bent affecting the operation of the device.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 has identified prior events.The most likely cause of this event is external forces applied to the component by other object and/or been drop.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The 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.

• Brand Name: NAVIO HANDPIECE TRACKER ARRAY
• 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: 12957056
• Report Number: 3010266064-2021-00846
• Device Sequence Number: 1728815
• Product Code: OLO
• UDI-Device Identifier: 00885556628577
• UDI-Public: 00885556628577
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 05/03/2022

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: PFSR120010
• Device Catalogue Number: PFSR120010
• 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: 11/17/2021
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 05/04/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANSPACH EMAX: PFSR101209, SNK02311117205; NAVIO SURGICAL SYSTEM US: NPFS02000, SN (B)(6)
• Patient Sex: Unknown