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

Model Number	PFSR101092
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results of investigation: the returned tissue protector did not appear to be significantly bent.Four bone pins were dropped down the two guides and each one dropped all the way through without any issue.The returned tissue protector is not bent, no problem found.The issue was reported to be noticed by the scrub technician and recon representative.It is possible that there was debris in the tissue protector guide that was causing the bone pin to go through it at an angle, but since we were not present at the time of the case we cannot confirm or deny this.
Event or Problem Description
It was reported by the scrub tech and recon rep that the tissue protector was slightly bent on one side.The pin slid nicely through one guide, but had a difficult time sliding through the other.There was no patient involvement.Device was not during use when event occurred.
Additional Manufacturer Narrative
Correction: a1.
Additional Manufacturer Narrative
The navio soft tissue protector, (pn 101092), 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 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.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
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• Manufacturer Contact: richard confer ; 2828 liberty ave; suite 100; pittsburgh, pa
• MDR Report Key: 9706213
• Report Number: 3010266064-2020-00034
• Device Sequence Number: 3603261
• Product Code: OLO
• UDI-Device Identifier: 00885556628713
• UDI-Public: 00885556628713
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2022

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: PFSR101092
• Device Catalogue Number: PFSR101092
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/09/2019; 09/28/2022
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 02/24/2020; 09/30/2022
• 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
• Patient Sex: Unknown