MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT TRIAL SZ 5 15 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TIBIAL INSERT TRIAL SZ 5 15 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, during impaction, the surgeon was attempting to trial a tibial insert.He was having some difficulty seating the insert, so he tried impacting it with the appropriate instrument and a small piece broke off.One piece came off during impaction and was retrieved.Patient was revised to cr tibial insert, size 5, 15mm.There was no surgical delay/prolongation.Patient was last known to be in stable condition.Photo received.The device will be return.As of note: "patient revision reported under mfr# 1038671-2022-00211.".
Additional Manufacturer Narrative
After further review of additional information received the following sections d9, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the broken instruments reported was likely the result of impaction forces being applied to the groove during trialing which led to the observed fracture.The most probable root cause associated with the reported event of "broken / non-functional¿ is associated with a partial or full-thickness crack in the device materials.

• Brand Name: TIBIAL INSERT TRIAL SZ 5 15 MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13712908
• Report Number: 1038671-2022-00251
• Device Sequence Number: 20192083
• Product Code: JWH
• UDI-Device Identifier: 10885862042415
• UDI-Public: 10885862042415
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: TIBIAL INSERT TRIAL SZ 5 15 MM
• Device Catalogue Number: 201-25-15
• 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: 02/21/2022
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male