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

Model Number	320-20-42
Health Effect - Clinical Codes	Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Section h10: (h3) all information will be captured in 1038671-2019-00525.Report was found to be a duplicate.

• Brand Name: EQUINOXE
• Common Device Name: 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
• Report Number: 1038671-2019-00526
• Device Sequence Number: 2579444
• Product Code: KWT
• UDI-Device Identifier: 10885862086587
• UDI-Public: 10885862086587
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention