MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number SMALL SUPERIOR/POSTERIOR AUGGLENOID PLATE,RIGHT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/30/2023

Event Type  Injury  

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 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.

• Brand Name: EQUINOXE
• Type of Device: 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
• MDR Text Key: 313934977
• Report Number: 1038671-2023-00820
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10885862534927
• UDI-Public: 10885862534927
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2023

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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/25/2023
• Date Device Manufactured: 08/10/2022
• 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 Sex: Female