MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SOFT TISSUE PROTECTOR; 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	01/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during placement of the tibial array pins, a pin became lodged in the tissue protector.This was removed manually, however it was unable to dislodge the pin from the tissue protector.A second tray was opened and another tissue protector was given to the surgeon.While attempting to place an array pin with the second tissue protector, the pin also became lodge in the protector.The pins were placed manually and the case proceeded without incident.
Additional Manufacturer Narrative
The navio soft tissue protector, (pn 101092), used in treatment was returned for a prior investigation and discarded.A relationship between the reported event and the device was established.A photo of the device from the prior investigation showed that the bone pin was stuck in the tissue protector.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 provides instructions for using the tissue protector.Specifically, the guide provides 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 in tr0979 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.Based on prior complaints received, it is likely that the event occurred due to the reported failure.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 SOFT TISSUE PROTECTOR
• 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 ; 2828 liberty ave; suite 100; pittsburgh, PA 15222
• MDR Report Key: 9742783
• Report Number: 3010266064-2020-00051
• Device Sequence Number: 16594869
• Product Code: OLO
• UDI-Device Identifier: 00885556628713
• UDI-Public: 00885556628713
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: PFSR101092
• Device Catalogue Number: PFSR101092
• 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: 01/08/2018
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 02/22/2020
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 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 Age: 51 YR
• Patient Sex: Female