MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; Q REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM

Model Number 320-20-42

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 321-20-00, (b)(4) - equinoxe reverse shoulder drill kit; 320-15-05, (b)(4) - eq rev locking screw; 320-20-00, (b)(4) - eq reverse torque defining screw kit; 320-10-00, (b)(4) - equinoxe reverse tray adapter plate tray +0; 300-01-09, (b)(4) - equinoxe, humeral stem primary, press fit 9mm; 320-01-42, (b)(4) - equinoxe reverse 42mm glenosphere; 320-15-01, (b)(4) - eq rev glenoid plate; 320-20-42, (b)(4) - eq rev compress screw lck cap kit, 4.5 x 42mm.

Event Description

It was reported as suspected infection.Baseplate loosened and screw broke due to micro-motion.Surgeon left in the broken part of the screw because he couldn¿t get it out.There would be more damage retrieving it than leaving it.All implants removed from original case and put in a makeshift spacer.No adverse reaction to patient.

Manufacturer Narrative

Section h10: (h3) all information will be captured in 1038671-2019-00525.Report was found to be a duplicate.

• Brand Name: EQUINOXE
• Type of Device: Q REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9207845
• MDR Text Key: 189076154
• Report Number: 1038671-2019-00526
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086587
• UDI-Public: 10885862086587
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

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 Expiration Date: 05/15/2022
• Device Model Number: 320-20-42
• Device Catalogue Number: 320-20-42
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention