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	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that, after a navio-assisted surgery, the navio handpiece thumberscrew was found fractured.There was no delay.Since incident occurred after the procedure, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: the navio handpiece thumberscrew, part number pfsr100026, serial unk and used for treatment, was not returned for evaluation.A relationship between the reported event and the device could not be established.A visual/functional inspection cannot be completed as no device was returned for evaluation.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, or field service report.A complaint history review for similar reported/confirmed complaints has identified prior events.A historical capa, hhe/pra, field action review was not completed.The product was not returned and no evidence was made available to link the complaint to a capa, hhe/pra, field action.No probable contributing factors could be attributed to this complaint.This failure is an identified failure mode within the risk assessment.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
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12474746
• Report Number: 3010266064-2021-00641
• Device Sequence Number: 19801713
• Product Code: OLO
• UDI-Device Identifier: 00885556648421
• UDI-Public: 00885556648421
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB00043/NAVIO SURGICAL SYSTEM JAPAN
• Patient Sex: Unknown