MAUDE Adverse Event Report: EXACTECH, INC. SMALL SUPERIOR/POSTERIOR AUGGLENOID PLATE,RIGHT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	SMALL SUPERIOR/POSTERIOR AUGGLENOID PLATE,RIGHT
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: serial #: (b)(4) category #: a10012 - gps implant kit v2, serial #: (b)(4), category #: 320-36-03 - 145-deg pe 36mm hum liner +2.5, serial #: (b)(4), category #: 320-31-36 - glenosphere, 36mm, serial #: (b)(4), category #: 320-10-00 - equinoxe reverse tray adapter plate tray +0, serial #: (b)(4), category #: 531-55-88 - ergo gps 3.2mm drill kit sterile, serial #: (b)(4), category #: 320-15-05 - eq rev locking screw, serial #: (b)(4), category #: 320-20-00 - eq reverse torque defining screw kit, serial #: (b)(4), category #: 531-78-20 - shouldr gps hex pins kit, serial #: (b)(4), category #: 300-30-10 - equinoxe preserve stem 10mm, serial #: (b)(4), category #: 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, serial #: (b)(4), category #: 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, serial #: (b)(4), category #: 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, serial #: (b)(4), category #: 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported, a female patient who had a right total shoulder arthroplasty on (b)(6)2023, at a 6 week post op follow up appointment, a coracoid tip avulsion fracture was determined.The surgeon indicated he assumed it was related to using coracoid tracker/screws.The patient was treated non-operative.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: a, b, c, d, e, f, g.The reason for the post operative bone fracture reported cannot be conclusively determined but may be related to implant positioning, patient bone quality, a trauma, and/or another patient related condition.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: SMALL SUPERIOR/POSTERIOR AUGGLENOID PLATE,RIGHT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16807226
• Report Number: 1038671-2023-00820
• Device Sequence Number: 19592462
• Product Code: PHX
• UDI-Device Identifier: 10885862534927
• UDI-Public: 10885862534927
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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 Model Number: SMALL SUPERIOR/POSTERIOR AUGGLENOID PLATE,RIGHT
• Device Catalogue Number: 320-35-08
• 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: 03/31/2023
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female