MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PRESERVE STEM 6MM

Model Number 300-30-06

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 320-10-00, 6867294 - equinoxe reverse tray adapter plate tray +0.320-20-00, 6811300 - eq reverse torque defining screw kit.

Event Description

As reported, during a left shoulder procedure on a male patient, after the stem and the tray were assembled, the surgeon implanted the assembly into humerus.At that time, he found one (1) small fragment on surface of greater tubercle.He picked it up from surgical field appropriately.It was unknown where the fragment came from.The facility has a third party (lab) analyze the fragment using icp mass spectrometer, and as a result, this fragment material was detected with high possibility as ti alloy.The devices were implanted; however, the fragment is to be returned for evaluation.

Manufacturer Narrative

Section h10: h3: the origin of the fragment reported cannot be determined because all of the implants utilized are made from the same titanium alloy, ti-6al-4v.The surgeon responded appropriately after noticing the fragment and removed it from the wound site.No additional fragments are visible in the provided x-ray images.

• Brand Name: EQUINOXE
• Type of Device: PRESERVE STEM 6MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12343766
• MDR Text Key: 267312662
• Report Number: 1038671-2021-00403
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• Combination Product (y/n): N
• PMA/PMN Number: K162726
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 300-30-06
• Device Catalogue Number: 300-30-06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention