MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO LONG ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSR110006
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that, during the milling stage in a navio assisted surgery, it was found that there were black fumes coming from the drill.The navio long attachment and exposure control guard became hot.The surgery was continued, without significant delays, using the navio long attachment from other set and with the same technique.The patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
H3, h6: the navio long attachment, p/n pfsr110006, lot 86885, 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.Some smoke appeared during testing and some debris can be observed inside the attachment.The most likely cause of this event is due to degradation/disintegration of the long attachment internal bearings.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 similar events.A historical escalation event review was completed.The review determined that prior escalation actions are applicable to the scope of this complaint however no further escalation action is required.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.No changes as a result of investigation.Bearing disintegration is associated with wear and tear over time.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 LONG ATTACHMENT
• 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: 13152351
• Report Number: 3010266064-2022-00007
• Device Sequence Number: 20186558
• Product Code: OLO
• UDI-Device Identifier: 00885556628607
• UDI-Public: 00885556628607
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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: PFSR110006
• Device Catalogue Number: PFSR110006
• Device Lot Number: (10) 86885
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 12/20/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB00036
• Patient Sex: Unknown