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

Model Number	PFSR101092
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported failure mode is a known issue and the surgeon was unable to release the pin from the tissue protector due to the damage incurred to the pin from incorrect usage.Also the device shows human tissue stuck in the threads inside of the tissue protector and scoring on the inner diameter in the shape of the screw threads.Therefore the screws, in addition to binding due to human tissue in the threads, are also binding on the inside of the tissue protector.
Event or Problem Description
It was reported that during surgery doctor placed tibia bone pins and the tissue protector got stuck on the pins.Both pins were in, and one was in too far to take it out using the drill.Doctor tried knocking the tissue protector loose with a mallet but was unsuccessful and was able to get one of the pins out using the drill, and then used the tissue protector to unscrew the pin out of the tibia.No patient injuries or surgical delays reported.
Additional Manufacturer Narrative
Correction: b1, b2 and h1 were updated to report type adverse event.
Additional Manufacturer Narrative
The device, used in treatment, was returned for a prior investigation and was discarded.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.A complaint history review found similar reports, this issue will continue to be monitored.The surgical technique guide released at the time of the complaint provides instructions for using the tissue protector.Specifically, the guide does provide instruction on how to prepare the bone pin insertion location on the patient and how to insert the tissue protector within that location.The complaint does not suggest that the user deviated from these instructions.Moreover, as part of the functional evaluation that replicated the issue, the test operator followed the instructions provided in the surgical technique guide and experienced the bone pin getting stuck in the tissue protector.Accordingly, product labeling has been ruled out as a cause of the complaint.This failure is an identified failure mode within the risk file.There was a relationship established between the reported event and the device; photos of the device from the prior investigation showed that the bone pin was stuck in the tissue protector.The malfunction is due to a design issue due to the inner diameter of the tissue protector lumen diameter relative to the major diameter of the bone pin.Binding of the bone screw to the tissue protector is primarily due to tissue being wrapped around the threads.However, initial pin misalignment and bending of the pin are also contributing factors.Hhe-2020-12-pl and capa 200017 were opened as corrective actions to address this issue.As a result of the remedial investigation, we have thoroughly investigated the complaint per the criteria as required by 21 cfr 820.198(d).

• Brand Name: NAVIO HANDPIECE
• 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: rick confer ; 2905 northwest; blvd ste 40; plymouth,, MN 55441
• MDR Report Key: 9677408
• Report Number: 3010266064-2020-00027
• Device Sequence Number: 2383231
• Product Code: OLO
• UDI-Device Identifier: 00885556628713
• UDI-Public: 885556628713
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PFSR101092
• Device Catalogue Number: ORPFSR101092
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2014
• Supplement Date Received by Manufacturer: 09/01/2014; 09/01/2014; 10/21/2022
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 02/06/2020; 02/23/2020; 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1634-2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown