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	08/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During surgical use, upon removal of the trial segment from the stem in situ, the 4 "legs" of the trial broke.The pieces were retrieved and accounted for.No surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.Pending device return.
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 (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
Corrections: b1, b2, h1.
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 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15349299
• Report Number: 1038671-2022-01026
• Device Sequence Number: 20134592
• Product Code: LXH
• UDI-Device Identifier: 10885862267719
• UDI-Public: 10885862267719
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/20/2026

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 25
• Device Catalogue Number: 309-10-25
• Device Lot Number: 124859003
• 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: 08/16/2022
• Supplement Date Received by Manufacturer: 01/17/2023; 01/17/2023; 04/13/2026
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 02/01/2023; 05/30/2023; 04/20/2026
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown