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

Model Number	PFSR100026
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a navio-assisted surgery, the navio handpiece thumberscrew fractured easily when the surgeon tightened it.The procedure was finished with a smith and nephew back up device without significant delays.The patient was not harmed.
Additional Manufacturer Narrative
H10: internal complaint reference: case(b)(4) h3, h6: the navio handpiece thumbscrew, part pfsr100026 used for treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may be associated with over tightening with excessive force by the user.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.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO HANDPIECE THUMBERSCREW
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 12000894
• Report Number: 3010266064-2021-00447
• Device Sequence Number: 19689657
• Product Code: OLO
• UDI-Device Identifier: 00885556648421
• UDI-Public: 00885556648421
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/04/2021

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: Health Professional
• Device Model Number: PFSR100026
• Device Catalogue Number: PFSR100026
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1