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

Model Number 320-35-07

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/07/2022

Event Type  Injury  

Event Description

It was reported via clinical study, that intra-op, the 76 yo female patient sustained a scapular fracture of the tip of the coracoid through anterior screw, likely from pull of anterior glenoid retractor.There was no action taken.The patient¿s outcome was last known as continuing.The case report form indicates this event is possibly related to device and definitely related to procedure.

Manufacturer Narrative

Concomitants: serial #: (b)(4) category #: 320-40-00 - 145-deg pe 40mm hum liner +0.Serial #: (b)(4) category #: 300-30-09 - equinoxe preserve stem 9mm, serial #: (b)(4) category #: 320-31-40 - glenosphere, 40mm.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 #: 320-10-00 - equinoxe reverse tray adapter plate tray +0.Serial #: (b)(4) category #: 531-78-20 - shouldr gps hex pins kit.Serial #: (b)(4) category #: 320-20-00 - eq reverse torque defining screw kit.Serial #: (b)(4) category #: 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.Serial #: (b)(4) category #: 315-35-00 - glnd kwire.Serial #: (b)(4) category #: 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.Serial #: (b)(4) category #: 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.Serial #: (b)(4) category #: 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.

• Brand Name: EQUINOXE
• Type of Device: 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: 16570566
• MDR Text Key: 311560144
• Report Number: 1038671-2023-00457
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862534910
• UDI-Public: 10885862534910
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-35-07
• Device Catalogue Number: 320-35-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White