MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE TORQUE DEFINING SCREW KIT

Model Number 320-20-00

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 320-42-03, (b)(4)- equinoxe reverse 42mm humeral liner +2.5; 320-15-05, (b)(4)- eq rev locking screw; 320-10-05, (b)(4)- equinoxe reverse tray adapter plate tray +5; 300-01-19, (b)(4)- equinoxe humeral stem primary press fit 19mm; 320-01-42, (b)(4)- equinoxe reverse 42mm glenosphere.

Event Description

This revision for the (b)(6) y/o male was the second revision of the patient's equinoxe reverse shoulder.The patient came back to the office after the first revision with the same issue a couple of months later.The surgical plan was to replace the reverse torque defining screw and see if the original shoulder stem was stripped.The shoulder stem was removed and we replaced with a new larger stem-size19, a new proximal humeral tray, fixed angle torque defying screw, glenosphere, glenosphere screw, and reverse liner.Upon review it seemed that the original size 17 humeral stem was stripped.At post-op follow up with the surgeon, the patient is doing fine following surgery.This was the patient second revision due to the compromised threads in the stem that caused the torque defining screw to back out.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of not replacing the humeral stem during the first revision, which led to implanting a new torque defining screw into a humeral stem with damaged threads.This deformation likely did not allow for the new torque screw to be fully seated during the first revision surgery, resulting in the second torque defining screw backing out of the humeral stem.

• Brand Name: EQUINOXE
• Type of Device: REVERSE TORQUE DEFINING SCREW KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9841526
• MDR Text Key: 189055221
• Report Number: 1038671-2020-00245
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-20-00
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR