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

Model Number	PFSR120010
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).(b)(6).
Event or Problem Description
It was reported that, during a navio assisted ukr surgery, the handpiece would not calibrate.They switched to new handpiece and found that there was a rock in the navio handpiece tracker array when putting it on a flat surface suggesting that it has become deformed.The procedure was finished with a smith and nephew back up device without significant delays.The patient was not harmed.
Additional Manufacturer Narrative
Results of investigation: the device, navio handpiece tracker array, part number pfsr120010, used for treatment was not returned for evaluation, thus a visual and functional evaluation could not be conducted.A relationship between the reported event and the device could not be established.The reported problem was not confirmed.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a device history record or non conformance investigation.A complaint history review for similar reported/confirmed complaints found similar events.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.This failure is an identified failure mode within the risk assessment and the anticipated risk level is still adequate.Although the reported problem was not confirmed factors that may have contributed to the reported symptom may have been associated with mishandling of the product.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 TRACKER ARRAY
• 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: 12974704
• Report Number: 3010266064-2021-00860
• Device Sequence Number: 4789826
• Product Code: OLO
• UDI-Device Identifier: 00885556628577
• UDI-Public: 00885556628577
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: PFSR120010
• Device Catalogue Number: PFSR120010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2021
• Supplement Date Received by Manufacturer: 02/12/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 02/16/2022
• 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
• Patient Sex: Unknown