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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MMX152MM ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MMX152MM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB00031
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference case-(b)(4).
 
Event Description
It was reported that at the end of a tka surgery, the navio bone pin 4. 0mmx152mm failed just above the black ring. From the photo provided, it was noticed broken at the top. It happened while in use inside the patient and there was no need of back-up. The procedure was completed, with a non-significant delay.
 
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Brand NameNAVIO BONE PIN 4.0MMX152MM
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
5123913905
MDR Report Key13080449
MDR Text Key282973732
Report Number3010266064-2021-00900
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB00031
Device Catalogue NumberROB00031
Device Lot Number21FT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/02/2021
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

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