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

Model Number	PFSR120010
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tracker frame on hand piece was loose when we arrived to cut peg holes for femur.So the drill showed us that we were right on peg holes, but when surgeon finished drilling peg holes he verified it with point probe and the point probe showed itself at 3-4 mm superior of the both peg holes (directly north).Tracker array was then tightened and then reverified with point probe and it was corrected.

• 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: 9135141
• Report Number: 3010266064-2019-00112
• Device Sequence Number: 3185401
• Product Code: OLO
• UDI-Device Identifier: 00885556628577
• UDI-Public: 00885556628577
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152574
• 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): 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PFSR120010
• Device Catalogue Number: PFSR120010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention