MAUDE Adverse Event Report: APTIS MEDICAL APTIS DRUJ

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.

• 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 Key: 13018493
• MDR Text Key: 285057513
• Report Number: 3004521401-2021-00001
• Device Sequence Number: 1
• Product Code: KXE
• UDI-Device Identifier: B013DRUJLP100
• UDI-Public: B013DRUJLP100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142569
• Number of Events Reported: 1
• 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

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DRUJLP10
• Device Catalogue Number: DRUJLP10
• Device Lot Number: 9448235
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White