MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE THUMBERSCREW

Model Number	PFSR100026
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up for a navio assisted ukr surgery the navio handpiece thumberscrew was broken during tightening.They were able to replace the thumbscrew and retrieve broke components.The procedure was completed, without delay, using a s+n back-up device.As this event was prior to surgery, there was no patient involvement.This is the first of two events.
Additional Manufacturer Narrative
H3, h6: the navio thumbscrew p/n 100026 intended for use in treatment was returned.The reported problem was visually confirmed.The thumbscrew is broke in half.Although the reported problem was visually confirmed, a functional evaluation could not be performed due to broken/damaged parts.The thumbscrew is broken in half.A review of device records using the nc database(s), (legacy bbt, caweb4 and smartsolve) confirmed no abnormalities were reported on this device during manufacture.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of this event is over tightening with excessive force by the user.Per the navio surgical system user's manual "to close and lock the clamshell, it is recommended to twist the thumbscrew by hand clockwise, until it is tightened securely." to attach the handpiece tracker, twist the thumbscrews clockwise by hand and then use the t-handle wrench to tighten the thumbscrews until the handpiece tracker array is firmly attached to the handpiece.Note: do not overtighten the thumbscrews." 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 HANDPIECE THUMBERSCREW
• Common Device Name: NAVIO HANDPIECE THUMBERSCREW
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 11890099
• Report Number: 3010266064-2021-00415
• Device Sequence Number: 1388160
• Product Code: OLO
• UDI-Device Identifier: 00885556648421
• UDI-Public: 00885556648421
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• 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): 07/19/2021

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: No Information
• Device Model Number: PFSR100026
• Device Catalogue Number: PFSR100026
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 07/17/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/19/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NAVIO SURGICAL SYSTEM US