MAUDE Adverse Event Report: EXACTECH, INC. MIDDLE SEGMENT TRIAL 75; TEMPLATE

Model Number	MIDDLE SEGMENT TRIAL 75
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, when taking the middle segments apart to remove from trialing, the tip that connects to the proximal segment snapped off.All broken pieces were then retrieved from patient and thrown out.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays or images.The device is not available for evaluation because piece was thrown out in case.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Section h10: (h3) the broken instrument reported was likely the result of not considering specific performance requirements to capture user needs and design inputs (instrument durability during reprocessing/sterilization as well as force applied over lifetime of device).Due to user needs and dis not being captured, testing was not executed to verify instrument/material durability over the lifetime of the device.
Additional Manufacturer Narrative
H6: corrected the following: medical device problem code, investigation findings, investigation conclusions.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that the event did not involve a death or serious injury, nor would be likely to cause or contribute to a death or serious injury if the reported malfunction were to recur.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: MIDDLE SEGMENT TRIAL 75
• Common Device Name: TEMPLATE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17628947
• Report Number: 1038671-2023-02058
• Device Sequence Number: 20451422
• Product Code: HWT
• UDI-Device Identifier: 10885862267733
• UDI-Public: 10885862267733
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MIDDLE SEGMENT TRIAL 75
• Device Catalogue Number: 309-10-75
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 12/13/2023; Not provided; 12/16/2025
• Initial Report FDA Received Date: 08/27/2023
• Supplement Report FDA Received Date: 04/18/2024; 11/06/2024; 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male