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

Model Number	PFSR110008
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during lab/demo, one of the tracker clamps was loose and not clamping properly.No patient involved.
Additional Manufacturer Narrative
H10 h6: the reported device, was intended for use for treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review identified prior similar events.A factor that could have contributed to the reported issue is if there was damage to the tracker clamp, caused by wearing out the retaining pin by repeatedly unthreading the thumbscrew into the pin with force.Over time the pin wears until the thumbscrew is able to the threaded past the pin and the tracker clamp is able to be disassembled.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO TRACKER ARRAY CLAMP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9999268
• Report Number: 3010266064-2020-01392
• Device Sequence Number: 3159217
• Product Code: OLO
• UDI-Device Identifier: 00885556628560
• UDI-Public: 00885556628560
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2020

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: PFSR110008
• Device Catalogue Number: PFSR110008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 04/25/2020
• Supplement Report FDA Received Date: 08/16/2020
• 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: Required Intervention