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

Catalog Number	PFSR101092
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/11/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Surgeon elected to use a manual drill directly on the bone screw, in contravention with the surgical technique guide.Using a manual drill results in high bend forces on the screw and damage to the thread.In addition the surgeon elected to place the first pin without the use of the tissue protector, which can result in misalignment and potential sticking after placing the second pin.The surgeon was unable to release the pin from the tissue protector due to the damage incurred to the pin from incorrect usage.This event was the result of a use error of the tissue protector that did not result in any serious injury to the patient; the tissue protector and pins were safely removed.It is our conclusion that this event does not constitute an event reportable pursuant to 21 cfr part 803.
Event or Problem Description
It was reported that during surgery the tissue protector got stuck on the bone pin while putting the pins in the tibia.Because the tissue protector was stuck on the pin and the pin was in the leg, the only way to get it off was to try and remove the pin and the protector together.The surgeon tried using the allen t-wrench to remove the bone pin and then the pin broke.Then doctor tried using mallet to remove the tissue protector and bone pin by hitting it.While doing this, the handle of the tissue protector broke off and was eventually able to get the pin and protector off by continuing to hit it.Then had to go in and remove the part of the pin that broke off.After all, it was possible to place another bone pin off to the side and proceed with the case.No surgical delays confirmed.
Additional Manufacturer Narrative
A1 and attachment updated.- attachment: [memo 5 feb 20.Pdf].
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.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.(b)(4) 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
• Manufacturer Contact: rick confer ; mcbride; 9600 broadway extension; oklahoma city, TN 73114 ; 0447940038246
• MDR Report Key: 9677383
• Report Number: 3010266064-2020-00021
• Device Sequence Number: 502181
• Product Code: OLO
• UDI-Device Identifier: 00885556628713
• UDI-Public: 885556628713
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PFSR101092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/11/2014
• Supplement Date Received by Manufacturer: 04/11/2014; 10/21/2022
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 02/06/2020; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown