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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES UNKNOWN CORI DEV; ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES UNKNOWN CORI DEV; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 74013489
Device Problem Mechanical Jam (2983)
Patient Problem Injury (2348)
Event Date 07/23/2020
Event Type  Injury  
Event Description
It was reported that during a cori tka procedure, when using the 3.2 mm x 110 mm speed pins on the tibia, the pin got stuck in the speed pin driver.They tried to separate the pin from the driver, but it remained stuck and completely pulled out of the tibia as he pulled on the drill.They switched to the 4.0 x 127 mm bone pin for the tibia.They were able to resume without any issue.
 
Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this complaint from the unites states reports that during a cori total knee arthroplasty the camera kept disconnecting and while using the speed pin quick connect adapter ¿ the pin got stuck in the driver and pulled completely out of the tibia.The surgeon switched to the 4.0 x 127 mm bone pin for the tibia.They were able to resume without any issue.There was no impact/harm/injury as a result of this reported event.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
 
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Brand Name
UNKNOWN CORI DEV
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
MDR Report Key10425642
MDR Text Key203502986
Report Number3010266064-2020-01718
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number74013489
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/23/2020
Initial Date FDA Received08/19/2020
Supplement Dates Manufacturer Received05/24/2021
Supplement Dates FDA Received05/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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