MAUDE Adverse Event Report: EXACTECH, INC. MIDDLE SEGMENT TRIAL 25; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	MIDDLE SEGMENT TRIAL 25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10:(h3) pending evaluation.
Event or Problem Description
It was reported that when using the 25mm segment trial 1 of the plastic tabs broke off the trial.The trial was still able to be used and there was no delay to the surgery or any plastic pieces left in the patient.No parts or pieces left in the patient.No surgical delay/prolongation.No patient information reported.Device is returning.
Additional Manufacturer Narrative
H3: as determined, 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.

• Brand Name: MIDDLE SEGMENT TRIAL 25
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18059498
• Report Number: 1038671-2023-02662
• Device Sequence Number: 20480687
• Product Code: LXH
• UDI-Device Identifier: 10885862267719
• UDI-Public: 10885862267719
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• 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
• Report Date (Section B): 02/10/2024

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: MIDDLE SEGMENT TRIAL 25
• Device Catalogue Number: 309-10-25
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 02/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Sex: Unknown