MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE COMPRESSION SCREW

Model Number 320-20-00

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 320-10-00, 58097005- equinoxe reverse tray adapter plate tray +0.320-02-42, 51488016 - rs expanded glenosphere 42mm, +4mm offset.320-42-03, equinoxe reverse 42mm humeral liner +2.5.320-15-01, 580097007 - eq rev glenoid plate.4x screws.

Event Description

As reported, approximately 7 years postop, this (b)(6) y/o male patient¿s left shoulder became unstable and loose over time.During the revision, the screws we found fractured, the cause of the fractures is unknown, but the center cage of the baseplate did not have any through growth.The baseplate and glenosphere were revised to a competitor mini.The stem stayed in the patient, the tray and the liner were revised.The patient was last known to be in stable condition following the event.The devices will not return due to facility policy.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of loosening of the glenoid baseplate and fracture of multiple compression screws, which help secure the baseplate to the glenoid bone.Due to the limited information available, the order of events cannot be determined at this time.Section h11: *the following sections have corrected information: (d2b) common device name: reverse compression screw.(d4) catalog number: unk, unique identifier (udi) #: unk.(d10) concomitant device(s): 320-10-00, (b)(6)- equinoxe reverse tray adapter plate tray +0.320-02-42, (b)(6) - rs expanded glenosphere 42mm, +4mm offset.320-42-03, equinoxe reverse 42mm humeral liner +2.5.320-15-01, (b)(6) - eq rev glenoid plate.320-20-00, eq revrse torque defining screw kit.(g4) pma/510(k)number: unk.

• Brand Name: EQUINOXE
• Type of Device: REVERSE COMPRESSION SCREW
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11626690
• MDR Text Key: 259099784
• Report Number: 1038671-2021-00156
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

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: 320-20-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 83