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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES ANSPACH EMAX 2 PLUS HAND PIECE - ROHS NAVIO

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BLUE BELT TECHNOLOGIES ANSPACH EMAX 2 PLUS HAND PIECE - ROHS NAVIO Back to Search Results
Catalog Number PFSR101209
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  Injury  
Event Description
It was reported that, during tka surgery with navio, during calibration, the system displayed a message to check the connections for the anspach drill. After further review, it was found that a pin was in the connector was recessed. The case was changed to manual procedure with a delay of fewer than 30 minutes. No other complications were reported.
 
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Brand NameANSPACH EMAX 2 PLUS HAND PIECE - ROHS
Type of DeviceNAVIO
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
5123913905
MDR Report Key11787524
MDR Text Key249390921
Report Number3010266064-2021-00329
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPFSR101209
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2021
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?
Type of Device Usage

Patient Treatment Data
Date Received: 05/06/2021 Patient Sequence Number: 1
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