MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC STEM EXT 16MM X 80MM

Model Number	02-012-60-1680
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during a revision on this (b)(6) y/o male patient¿s right knee, reported separately the bone fractured while the surgeon was impacting the constructed femur/stem trial.This took place during a revision, which is reported separately.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the revision reported based upon on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the bone fracture cannot be conclusively determined; however, it is most likely is related to the patient¿s underlying condition.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC STEM EXT 16MM X 80MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10549019
• Report Number: 1038671-2020-00521
• Device Sequence Number: 16902499
• Product Code: JWH
• UDI-Device Identifier: 10885862272232
• UDI-Public: 10885862272232
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2022
• Device Model Number: 02-012-60-1680
• Device Catalogue Number: 02-012-60-1680
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR