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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
Catalog Number NPFS02000
Device Problem Device Operational Issue (2914)
Patient Problem Bone Fracture(s) (1870)
Event Date 04/16/2018
Event Type  Injury  
Manufacturer Narrative
Investigation narrative: the field report details noted that the surgeon prepped the "lug holes" (aka post holes) on the tibia but did not prep the keel before impacting the tibial trial into the patient's tibia. The stride tibial trials are not designed to cut the keel or post holes through impaction, they are designed to be placed after both the post holes and the keel are prepped. This is not the intended use of the tibial trials (not intended to cut/prep the keel). The "navio surgical technique for use with the stride unicondylar knee system" recommends the use of the keel punch tool to prep the keel. For best accuracy results with the tibial component, it is recommended that the keel be cut out prior to placing the tibial trial component, using a 2 mm spherical bur in manual control mode. In the manual the user is given two options for keel prep (keel punch or 2 mm bur), neither one of them recommend impacting the tibial trial. There are other implant manufacturers that design their tibial trials to have keels that are able to be impacted for keel cuts, however stride was not designed with this intent as the keels on the trials are rounded and not sharp. There are no indications to suggest the device did not meet product specifications upon release into distribution.
 
Event Description
It was reported that the patient's tibial plateau was fractured upon impacting the tibial trial during a stride procedure. It was noted that the lug holes had been prepped but not the keel. The surgeon placed a plate and several screws into the anterior medial tibial face to repair the fracture. No further complications were reported.
 
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Brand NameNAVIO
Type of DeviceSTEROTAXIC 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 Key7509206
MDR Text Key108088212
Report Number3010266064-2018-00006
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberNPFS02000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/11/2018 Patient Sequence Number: 1
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