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

Model Number	PFSR120010
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before surgery, the handpiece tracker was bent.There was a backup device available and a delay of fewer than 30 minutes.No other complications were reported.

• 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: 10014738
• Report Number: 3010266064-2020-01561
• Device Sequence Number: 2953036
• Product Code: OLO
• UDI-Device Identifier: 00885556628577
• UDI-Public: 00885556628577
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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?: Yes
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 12/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1