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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NAVIO; STEROTAXIC INSTRUMENT, COMPUTER ASSISTED, PRODUCT CODE: OLO
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BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NAVIO; STEROTAXIC INSTRUMENT, COMPUTER ASSISTED, PRODUCT CODE: OLO Back to Search Results
Model Number NPFS02000
Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
Patient Problems No Information (3190); Insufficient Information (4580)
Event Date 10/23/2017
Event Type  malfunction  
Event Description
It was reported that during bone pin insertion through the tissue protector, one pin seized and it was not possible to remove it.The surgeon removed both items by unscrewing the pin and tissue protector together in a single piece.
 
Event Description
It was reported that during bone pin insertion through the tissue protector, one pin seized and it was not possible to remove it.The surgeon removed both items by unscrewing the pin and tissue protector together in a single piece.
 
Manufacturer Narrative
Disclaimer: smith & nephew is submitting the above report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.The report is based upon information obtained by smith & nephew, which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, smith & nephew, or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, smith & nephew or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the event described in this report.Correction: b1 and h1 were updated to report type adverse event.
 
Manufacturer Narrative
The navio soft tissue protector, (pn 101092), used in treatment was returned for a prior investigation and 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 (b)(4) 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).
 
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Brand Name
NAVIO
Type of Device
STEROTAXIC INSTRUMENT, COMPUTER ASSISTED, PRODUCT CODE: OLO
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW
2905 northwest blvd.
suite 40
plymouth MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd
ste. 40
plymouth MN 55441
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, PA 15222
4126833844
MDR Report Key7050341
MDR Text Key93585342
Report Number3010266064-2017-00017
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K160537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 10/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberNPFS02000
Device Catalogue NumberNPFS02000
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberZ-1634-2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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