MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-04
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Limb Fracture (4518)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when impacting the glenoid plate the glenoid fractured.The surgeon decided to replace the glenoid plate with one with a longer cage to get better fixation.The sup/post augment provided better fixation.There was a 15-30 min delay.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d6b, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the intraoperative bone fracture reported cannot be conclusively determined but may be related to a patient condition or high forces during broaching, reaming, exposure, or retraction.However, this cannot be confirmed based on the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18229606
• Report Number: 1038671-2023-02877
• Device Sequence Number: 6268857
• Product Code: KWT
• UDI-Device Identifier: 10885862186690
• UDI-Public: 10885862186690
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: Health Professional
• Device Catalogue Number: 320-15-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2023
• 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
• Patient Sex: Unknown