MAUDE Adverse Event Report: EXACTECH, INC. TRU TIBIAL ADAPTOR PLATE TRIAL/IMPLANT, SIZE 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	TRU TIBIAL ADAPTOR PLATE TRIAL/IMPLANT, SIZE 4
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation noted that revision reported was likely the result of human error was considered to be a cause of this failure.Two possible scenarios include using the incorrect size adapter plate or attempting to remove the adaptor plate with a tool other than the truliant drop rod handle, as stated per the operative technique.The geometry of the truliant drop rod handle, in addition to an appropriately constrained adaptor plate, as designed creates a scenario in which contact with the flexure is extremely difficult.The design lends to being susceptible to breakage if used incorrectly due to the use of ultem material with a thinner aspect under load.The most probable root cause associated with the reported event of "broken - retrieved from patient" is likely the result of using an osteotome to remove the adaptor plate and not the truliant drop rod handle, which likely led to fracturing of the central flexure.A risk assessment has been initiated to escalate this issue.
Event or Problem Description
As reported, during removal/withdrawal in a procedure on this male patient, the surgeon used an osteotome to remove adaptor plate and broke part of it.All pieces were recovered.The patient was not affected.

• Brand Name: TRU TIBIAL ADAPTOR PLATE TRIAL/IMPLANT, SIZE 4
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11678593
• Report Number: 1038671-2021-00171
• Device Sequence Number: 19595444
• Product Code: JWH
• UDI-Device Identifier: 10885862525451
• UDI-Public: 10885862525451
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2021

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 Model Number: TRU TIBIAL ADAPTOR PLATE TRIAL/IMPLANT, SIZE 4
• Device Catalogue Number: 02-029-25-4040
• Device Lot Number: 49048288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1