MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE SHOULDER SYSTEM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	320-35-02
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products:¿ (b)(4), (b)(4), gps implant kit v2, (b)(4), 320-36-00 , 145-deg pe 36mm hum liner +0, (b)(4), 320-10-00 ,equinoxe reverse tray adapter plate tray +0, (b)(4), 300-01-09 , equinoxe, humeral stem primary, press fit 9mm, (b)(4), 531-55-88 , ergo gps 3.2mm drill kit sterile, (b)(4), 320-20-00 - eq ,reverse torque defining screw kit, (b)(4), 320-20-26, eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(4), 320-20-26 - eq, rev compress screw lck cap kit, 4.5 x 26mm, (b)(4), 320-31-36, glenosphere, 36mm, (b)(4), 320-20-30 , eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(4), 531-78-20 , shouldr gps hex pins kit, (b)(4), 320-15-05,eq rev locking screw, (b)(4), 320-20-18 ,eq rev compress screw lck cap kit, 4.5 x 18mm.
Event or Problem Description
It was reported via clinical study that post-op the 69 yo female patient experienced a scapular spine fracture (type 3) without specific known event that was diagnosed during routine follow-up.There was no revision.Gps was used in the initial implant procedure. patient was advised to resume sling for 6 weeks.The patient¿s outcome was last known as continuing.The case report form indicates this event is definitely related to device and definitely related to procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4 (remove from initial report-suspect device(s) unknown), g4 (remove 501k from initial report-unknown), h4 (remove from initial report).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b3, d1, d4 (remove all from initial report-suspect devices unknown), g4 (remove 501k from initial report-unknown) h2, h6: medical device problem code, component code, type of investigation, investigation findings, investigation conclusion codes.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the fracture cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE SHOULDER SYSTEM
• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16492726
• Report Number: 1038671-2023-00379
• Device Sequence Number: 15106099
• Product Code: KWT
• UDI-Device Identifier: 10885862534873
• UDI-Public: 10885862534873
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K182536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2025

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: 320-35-02
• Device Catalogue Number: 320-35-02
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 11/17/2025; 11/17/2025
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 11/18/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White