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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BBT FOOTPEDAL ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO BBT FOOTPEDAL ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number PFSR120031
Device Problem Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2021
Event Type  Injury  
Event Description
It was reported that, during femoral bone cutting in a navio-assisted ukr surgery, a "drill footpedal cable is not connected. Re-establish connection and press 'dismiss' to continue. " message was displayed (case (b)(4)). After re-establishing the handpiece and the footpedal, the handpiece continue to stopped working and its test results were abnormal (many blank segments) (case (b)(4)). The case was aborted and the procedure was finished with manual instrumentation without any significant delays (fewer than 30 minutes). No patient was harmed.
 
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Brand NameNAVIO BBT FOOTPEDAL
Type of DeviceORTHOPEDIC 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
holly topping
7000 west william cannon drive
austin, TX 78735
MDR Report Key11814277
MDR Text Key250271381
Report Number3010266064-2021-00369
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556725597
UDI-Public885556725597
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K193120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPFSR120031
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/12/2021 Patient Sequence Number: 1
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