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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MM X 127MM ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MM X 127MM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number PFSD01008
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/04/2017
Event Type  malfunction  
Event Description
It was reported that the bone pin got stuck in the tissue protector and then bent when trying to get it out. It appeared that the bone pin torqued while being drilled which caused it to get lodged in tissue protector. A new bone pin was used to complete the procedure without using the tissue protector.
 
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Brand NameNAVIO BONE PIN 4.0MM X 127MM
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
richard confer
2828 liberty ave
suite 100
pittsburgh, PA 15222
MDR Report Key9747010
MDR Text Key188507345
Report Number3010266064-2020-00067
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 02/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPFSD01008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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