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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES STRIDE INSERT; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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BLUE BELT TECHNOLOGIES STRIDE INSERT; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number UNKNOWN
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 10/31/2014
Event Type  malfunction  
Event Description
It was reported that the trial insert broke when surgeon tried to take out of tibial tray.
 
Manufacturer Narrative
H10 h3, h6: the reported device, used for treatment, was returned for evaluation.Visual inspection of the returned device confirmed the trial poly was broken and was the older design.There was no part/serial/lot number provided for dhr review so it could not be concluded if the device met the manufacturing specifications.A complaint history review identified similar events.We were able to confirm there was a relationship established between the reported event and the device.The malfunction is likely due to the design of the poly trial.Subsequent changes to improve the design included removing snap features and adding a chamber to allow the trials to be inserted easily into the tibial trays by hand.A factor that could have contributed to this issue is if the user impacted the poly trial causing the thin section to break.Poly trials are designed to drop into the tibial tray with no force.
 
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Brand Name
STRIDE INSERT
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 Key9998638
MDR Text Key189909575
Report Number3010266064-2020-01165
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 07/29/2020
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 Model NumberUNKNOWN
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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