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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 BONE PIN 4 MM OD X 5.0 (127 MM) IN LG STEROTAXIC INSTRUMENT, COMPUTER ASSISTED

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BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NAVIO BONE PIN 4 MM OD X 5.0 (127 MM) IN LG STEROTAXIC INSTRUMENT, COMPUTER ASSISTED Back to Search Results
Catalog Number PFSR101111
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problem Bone Fracture(s) (1870)
Event Date 11/07/2018
Event Type  Injury  
Manufacturer Narrative
Investigation narrative: the navio surgical system surgical technique for total knee arthroplasty clearly states in the tibia tracker array placement section, "slowly drill the bone pin into the tibia, perpendicular to the bony surface, taking care to engage the opposing cortex and stop. " therefore, this was a preventable issue by the surgeon as the instructions for bone pin insertion clearly state to only engage the second cortex. The reporter noted in the field report that in future cases, the surgeon plans to stop penetration when the second cortex is engaged.
 
Event Description
It was reported that the posterior cortex of the patients tibia developed a small fracture across the bone pin sites during placement of the 4. 0 tibial pins. The pins were driven bi-cortically and a cracking sound was heard for each pin placed in the tibia; however, the surgeon opted to continue the procedure confident that the array construct was solid. The arrays were tightened by handling both the array clamp and pins while tightening with the t-handle. An x-ray was taken at the end of the procedure which confirmed the tibial fracture. The surgeon intends to modify the technique used for future pin placement to mitigate bi-cortical placement by slowing down the drill after breaking through the first cortex and stopping pin penetration once the second cortex is sensed to avoid breaking through the second cortex.
 
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Brand NameNAVIO BONE PIN 4 MM OD X 5.0 (127 MM) IN LG
Type of DeviceSTEROTAXIC INSTRUMENT, COMPUTER ASSISTED
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 Key8111664
MDR Text Key128637109
Report Number3010266064-2018-00015
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPFSR101111
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2020
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 Unkown

Patient Treatment Data
Date Received: 11/28/2018 Patient Sequence Number: 1
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