• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE TRACKER ARRAY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BLUE BELT TECHNOLOGIES NAVIO HANDPIECE TRACKER ARRAY; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number PFSR120010
Device Problem Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Date 09/06/2017
Event Type  malfunction  
Event Description
It was reported that upon inspection in the service centre, the handpiece tracker (b)(4) is bent.
 
Manufacturer Narrative
H10: h6: the device, intended to be used during treatment, was not returned.Therefore, visual inspection and functional testing could not be performed.However, the initial event description stated that the handpiece tracker was bent.If the handpiece tracker was the aluminum design, a factor that could have contributed to this event is that the aluminum material can bend more easily due to the nature of the forces placed on the handpiece tracker either via the surgeon's hand, dropping it, or any other forces.The material has been changed to stainless steel which makes the part much stronger and less susceptible to bending, thus, reducing the likelihood of this problem.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review was performed and found 23 similar reports of the failure.This issue will continue to be monitored.A relationship between the device and the reported could not be established.The root cause of the reported event could not be determined.No containment or corrective actions are recommended at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NAVIO HANDPIECE TRACKER ARRAY
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
MDR Report Key9993926
MDR Text Key190012253
Report Number3010266064-2020-00532
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPFSR120010
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/06/2017
Initial Date FDA Received04/23/2020
Supplement Dates Manufacturer Received06/26/2020
Supplement Dates FDA Received06/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-