MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SOFT TISSUE PROTECTOR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSR101092
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
For the reported failure mode binding of the bone screw to the tissue protector is primarily due to tissue being wrapped around the threads.However, initial pin misalignment, bending of the screws, and misuse of the tissue protector can also be contributing factors.
Event or Problem Description
It was reported that during surgery surgeon made tibial incision for tracking array and screwed in first tibial bone pin.Placed tissue protector over bone pin and screwed in second, but broke the head of the second bone pin in the process.Surgeon removed first tibial bone pin and attempted to remove tissue protector from damaged pin with no success.Took pin driver out of chuck and chucked drill directly to damaged bone pin.Surgeon was able to remove broken bone pin from the patients leg; however, even with the bone pin out of the leg, the bone pin could not be removed from the tissue protector.Case was delayed and surgery was completed with back-up devices.
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.While the complaint does suggest that the user may have deviated from these instructions for not inserting the pins in the correct sequence, the functional evaluation continues to suggest that the cause of the complaint concerns the design of the tissue protector.Specifically, 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.We could not confirm if there was a relationship established between the reported event and the device.Photos of the device were not provided for evaluation and the device was discarded after a prior investigation.However, 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; 2828 liberty ave; plymouth MN 55441
• Manufacturer Contact: richard confer ; 2905 northwest blvd ste 40; 2828 liberty ave; plymouth, MN 55441 ; 4126833844
• MDR Report Key: 9677395
• Report Number: 3010266064-2020-00024
• Device Sequence Number: 11428983
• Product Code: OLO
• UDI-Device Identifier: 00885556628713
• UDI-Public: 00885556628713
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2022

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: PFSR101092
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/13/2015
• Supplement Date Received by Manufacturer: 08/13/2015; 10/21/2022
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 02/23/2020; 10/25/2022
• 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: Unknown
• 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