MAUDE Adverse Event Report: APTIS MEDICAL APTIS DRUJ

Model Number	DRUJLP10
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was trying to get up out of a chair and felt the implant break.
Additional 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
• Common Device Name: 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
• Report Number: 3004521401-2021-00001
• Device Sequence Number: 12044010
• Product Code: KXE
• UDI-Device Identifier: B013DRUJLP100
• UDI-Public: B013DRUJLP100
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2025
• Device Model Number: DRUJLP10
• Device Catalogue Number: DRUJLP10
• Device Lot Number: 9448235
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White