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

Model Number	PFSR110006
Medical Device Problem Codes	Material Deformation (2976); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that, during femoral burring in a navio assisted tka surgery, the handpiece was making a loud screeching noise.The procedure was completed, without delay, using the same device, and the patient was not harmed.After the case, during instrument disassembly, it was noticed that the distal tip of the navio long attachment, where the bur is inserted, was flared out.The investigation found that the long attachment was not facilitating the bur loading due to loose bearings within the device, causing an obstruction.
Additional Manufacturer Narrative
H3, h6: the navio long attachment, part number pfsr110006, intended for use in treatment, was returned for evaluation.A relationship between the reported event and the device was established.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found related issues.The complaint was visually confirmed.The tip of the long attachment was trumpeted out.A functional evaluation was unable to be performed as the device could not facilitate loading a bur due to loose bearings withing the long attachment causing an obstruction.The most likely cause of this event is wear of the device due normal use.A historical escalation event review was completed.The review determined that prior escalation actions are applicable to the scope of this complaint and the owner has been notified to consider further escalation action.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 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: 13282365
• Report Number: 3010266064-2022-00032
• Device Sequence Number: 4835013
• Product Code: OLO
• UDI-Device Identifier: 00885556628607
• UDI-Public: 00885556628607
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Report Date (Section B): 05/27/2022

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
• 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: 01/04/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 05/27/2022
• 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: NPFS02000/NAVIO SURGICAL SYSTEM US
• Patient Sex: Unknown