MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT TRIAL SZ 3.5 13MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	02-013-35-3513
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that during this 57 y/o female patient's right knee revision, the logic style poly trial when trying to insert it into the knee with the cemented implants broke or snapped into two pieces.While the surgeon removed the 9mm ps poly that was in the patient from the original surgery and began trialing thicker options of the poly.The surgeon used the logic style 3.5mm - 13mm poly to trial and upon inserting the poly trail, the plastic broke or snapped into two pieces.The surgeon needed to use strength to be able to insert the poly for trialing.The surgery was delayed with having to remove the pieces of the trail, irrigate the knee site and start re-trialing with the truliant style of polys.All pieces were removed from the patient.The patient left the or stable.The broken implant was isolated, cleaned, and is being sent back to exactech and replaced.Revision stated in the summary is captured in (b)(4).
Additional Manufacturer Narrative
Section h10: h3: the fractured tibial insert trial reported may have been the result of years of surgical use, aggressive use, and subsequent sterilization cycles which led to crack initiation, propagation, and ultimate fracture of the device during trialing.Section h11: the following sections have corrected information: h6: component code: 4755, part/component/sub-assembly term not applicable.
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: LOGIC TIBIA PS MOD INSRT TRIAL SZ 3.5 13MM
• 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 ; 3523771140
• MDR Report Key: 15228408
• Report Number: 1038671-2022-00919
• Device Sequence Number: 5902099
• Product Code: LXH
• UDI-Device Identifier: 10885862004314
• UDI-Public: 10885862004314
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/28/2025

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: 02-013-35-3513
• Device Catalogue Number: 02-013-35-3513
• Device Lot Number: 09011462
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 03/07/2023; 10/28/2025
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 03/28/2023; 10/28/2025
• 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 Age: 57 YR
• Patient Sex: Female