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

Model Number	PFSR120010
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during lab/demo, handpiece error appeared saying that the drill has failed.The black attachment on the moving mechanism sheared off, and appears to have caused the fault.Two more handpieces were tried, and seemed to have power failures as well.The healthcare professionals tried to use them on the stations, and these didn't work either, and when tested afterwards both failed the handpiece tests.Also, handpiece tracker frame was dropped from the table, and was bent.No patient involved.
Additional Manufacturer Narrative
Results of investigation: the device was intended to be used during treatment and was returned for evaluation.The lot number for the device was not provided.However, all lots of pn 120010 distributed to the field from when the part number was first inspected to the complaint occurrence date were reviewed and there were no non-conformance found.There are no other issues that would potentially lead to a future performance issue.Therefore, the reported product met manufacturing specifications prior to being released for distribution.A complaint history review was performed and found similar events of the issue and will continue to be monitored.A relationship between the device and the reported event could be established.A functional evaluation was performed on the handpiece tracker array and found that it would rock indicating it was bent in the center.Additionally, the handpiece tracker array would not allow the handpiece to calibrate.The reported problem was confirmed.Therefore, the root cause of the reported event was due to mechanical component failure.No containment or corrective actions are recommended at this time.

• 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
• MDR Report Key: 9999253
• Report Number: 3010266064-2020-01384
• Device Sequence Number: 3159213
• Product Code: OLO
• UDI-Device Identifier: 00885556628577
• UDI-Public: 00885556628577
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 04/25/2020
• Supplement Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PFSR110137 NAVIO HANDPIECE, SERIAL (B)(6); ROB00049 NAVIO SURGICAL SYSTEM UK. SERIAL (B)(6)