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

Catalog Number	PFSR101092
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure, two navio soft tissue protectors had a bone pin stuck and there are difficult to separate.The procedure was continued with manual instrumentation and there were no delays.No other complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for investigation.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 (500197) provides instructions for using the tissue protector.This failure is an identified failure mode within the risk file.We were able to confirm if there was a relationship established between the reported event and the device.Visual inspection confirmed that the bone pin was stuck inside the tissue protector distal canula.A functional evaluation was performed and the lodged bone pins were removed by force.The threads on the bone pins contained tissue, further confirming the malfunction.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.A corrective action was opened as a result of this issue and a new design and part number, pn: 101420, has been released.The medical investigation found that this complaint from the united states reported that the navio tissue protector had a pin stuck in it and could not be used.Per complaint details, the issue was found prior to use.Based on the information provided, there was no patient injury/impact as the procedure was completed with manual instrumentation and there were no delays.Smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Our reference number: (b)(4).
Additional Manufacturer Narrative
Section h10: the device (pn 101092), used in treatment, was returned for investigation.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 (500197) provides instructions for using the tissue protector.This failure is an identified failure mode within the risk file.A relationship between the reported event and the device was established.Visual inspection confirmed that the bone pin was stuck inside the tissue protector distal canula.A functional evaluation was performed and the lodged bone pins were removed by force.The threads on the bone pins contained tissue, further confirming the malfunction.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.A corrective action was opened as a result of this issue and a new design and part number, pn 101420, has been released.Field actions were also taken for this part number due to a design issue.The medical investigation found that: this complaint from the united states reported that two navio tissue protectors had pins stuck in them and could not be used.Per complaint details, the issue was found prior to use.Based on the information provided, there was no patient injury/impact as the procedure was completed with manual instrumentation and there were no delays.Smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Internal complaint reference number: (b)(4).

• 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 avenue; suite 100, PA 15222 ; 4126833844
• MDR Report Key: 10319392
• Report Number: 3010266064-2020-01681
• Device Sequence Number: 2912325
• Product Code: OLO
• UDI-Device Identifier: 00885556628713
• UDI-Public: 885556628713
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2022

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 Catalogue Number: PFSR101092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 02/23/2021; 10/06/2022
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 02/24/2021; 10/07/2022
• 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 Sex: Unknown