MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY, PRESS FIT 15MM

Model Number	300-01-15
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during impaction phase of the procedure on this (b)(6) y/o male patient, the implant, broach trial, and reamer for a size 15 did not match sizes and surgeon ended up having a subsided stem."specifically trial and real implant." the surgeon had to ream the canal again and broach up a size in order to get implant to fit.Created a stressful situation for surgeon.This created a short delay with no harm to the patient.Patient was last known to be in stable condition following the event.Device to return.
Additional Manufacturer Narrative
Section h10: h3: the size discrepancy reported was likely the result of the stem trail's distal diameter being manufactured at mmc and proximal m/l width being undersized while the final implant's distal diameter being manufactured closer to lmc, which led to the stem trial sitting proud and the final implant subsiding.Additional contributing factor may include user error or over impacting when broaching the humerus or poor bone quality.

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL STEM PRIMARY, PRESS FIT 15MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11404350
• Report Number: 1038671-2021-00084
• Device Sequence Number: 14338898
• Product Code: KWT
• UDI-Device Identifier: 10885862079336
• UDI-Public: 10885862079336
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 300-01-15
• Device Catalogue Number: 300-01-15
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 08/12/2021
• 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
• Patient Age: 76 YR