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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE SCREW DRIVER INSTRUMENT, CUTTING, ORTHOPEDIC

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BLUE BELT TECHNOLOGIES NAVIO BONE SCREW DRIVER INSTRUMENT, CUTTING, ORTHOPEDIC Back to Search Results
Model Number PFSR110164
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/19/2019
Event Type  malfunction  
Event Description
It was reported that while using navio drill to remove bone pins the inside of the drill fell out. Another drill was used to complete procedure and no delays or patient injuries were reported.
 
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Brand NameNAVIO BONE SCREW DRIVER
Type of DeviceINSTRUMENT, CUTTING, ORTHOPEDIC
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN
Manufacturer Contact
rick confer
2828 liberty ave
suite 100
pittsburgh, PA 15222
MDR Report Key9448636
MDR Text Key188489511
Report Number3010266064-2019-00140
Device Sequence Number1
Product Code HTZ
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,Followup
Report Date 07/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPFSR110164
Device Catalogue NumberPFSR110164
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2021
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? No
Type of Device Usage Reuse

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