MAUDE Adverse Event Report: EXACTECH, INC. MIDDLE SEGMENT TRIAL 50; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	309-10-50
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this device was damaged.No other information provided at this time.
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 (material durability during reprocessing/sterilization as well as force applied over lifetime of device), which led to insufficient testing to demonstrate continued performance over time and resulted in fracture during surgical use.

• Brand Name: MIDDLE SEGMENT TRIAL 50
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16684500
• Report Number: 1038671-2023-00587
• Device Sequence Number: 18171928
• Product Code: LXH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

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 Catalogue Number: 309-10-50
• Device Lot Number: 101805002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 05/22/2023; 09/22/2026
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/13/2023; 09/22/2026
• 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
• Patient Sex: Unknown