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: pending evaluation.
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.
Additional Manufacturer Narrative
Section h11: the following sections have corrected information: (g4) date received by manufacturer: 14-mar-2023.

• 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: 16684546
• Report Number: 1038671-2023-00586
• Device Sequence Number: 7387342
• 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,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: 68112003
• 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: 03/14/2023; 05/22/2023; 09/22/2026
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 04/05/2023; 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