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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APTIS MEDICAL APTIS DRUJ

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APTIS MEDICAL APTIS DRUJ Back to Search Results
Model Number DRUJLP10
Device Problem Installation-Related Problem (2965)
Patient Problem Joint Dislocation (2374)
Event Date 11/17/2021
Event Type  Injury  
Event Description
Patient was trying to get up out of a chair and felt the implant break.
 
Manufacturer Narrative
Once notified via e-mail it was noted the cover had broken free from the radial plate and the plate itself was extremely dorsally angulated.Contact with the surgeon was made on (b)(6) 2021 to gather further information.The surgeon stated the patient felt the prosthesis break as she was using her arms to lift herself out of a chair.The surgeon stated that he did not follow the technical guidance and positioned the plate dorsally angulated due to the shape of the radius.He also acknowledged that all guidance requires the plate to be properly positioned but he felt the altered positioning would be acceptable.The device failed due to the mal-positioning which altered the forces passing through the device to an extreme.
 
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Brand Name
APTIS DRUJ
Type of Device
APTIS DRUJ
Manufacturer (Section D)
APTIS MEDICAL
3602 glenview ave
glenview KY 40025
Manufacturer Contact
bryan babb
3602 glenview ave
glenview, KY 40025
5024258584
MDR Report Key13018493
MDR Text Key285057513
Report Number3004521401-2021-00001
Device Sequence Number1
Product Code KXE
UDI-Device IdentifierB013DRUJLP100
UDI-PublicB013DRUJLP100
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial
Report Date 12/16/2021
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? No
Device Operator Lay User/Patient
Device Model NumberDRUJLP10
Device Catalogue NumberDRUJLP10
Device Lot Number9448235
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/17/2021
Initial Date FDA Received12/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
Patient SexFemale
Patient Weight89 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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