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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES STRIDE EM TIBIAL ALIGNMENT GUIDE ARM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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BLUE BELT TECHNOLOGIES STRIDE EM TIBIAL ALIGNMENT GUIDE ARM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number PFSR110012
Device Problem Mechanical Jam (2983)
Patient Problem No Information (3190)
Event Date 09/18/2014
Event Type  malfunction  
Event Description
It was reported that during a lab demo the rep was unable to lift the lever on the tibial alignment guide to allow the cutting block to be attached.No patient involved.
 
Manufacturer Narrative
H10 h3, h6: the device, intended for use in treatment, was returned for investigation.The customer reported that during a demonstration in the skills lab, it was found that the alignment guide would not allow the cutting block to be attached.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.A complaint history review found similar reports.Visual and functional inspection found that the problem reported was due to a misalignment of the leaf spring causing the pivot force to be too high to allow for the attachment lever.This was due to a manufacturing process error.A relationship between the device and the reported event could be established.
 
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Brand Name
STRIDE EM TIBIAL ALIGNMENT GUIDE ARM
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
MDR Report Key9994413
MDR Text Key188838410
Report Number3010266064-2020-00154
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
PMA/PMN Number
K123380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPFSR110012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2014
Date Manufacturer Received07/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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