MAUDE Adverse Event Report: EXACTECH, INC. 3 PEG PATELLA TRIAL 38MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	3 PEG PATELLA TRIAL 38MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
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 surgical use, the broken lug was lodged in the patella and it was removed.The female patient was last known to be in stable condition following the event.There was approximately a 5 minute delay.The device will not be returned for analysis as it was disposed by hospital.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g7, h2, h3 and h6 have been updated accordingly.(h3) the evaluation noted that revision reported was likely the result of surgical use and subsequent sterilization cycles over a 17-year timespan, which resulted in a fractured peg.However, this cannot be confirmed as the device was not returned for evaluation.The most probable root cause associated with the reported event of "broken - retrieved from patient" is associated with a partial or full-thickness crack in the device materials.
Additional Manufacturer Narrative
After further review of additional information received the following sections d10, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the broken instrument reported was likely the result of surgical use and subsequent sterilization cycles over a 17-year timespan, which resulted in a fractured peg.The most probable root cause associated with the reported event of "broken - retrieved from patient" is associated with a partial or full-thickness crack in the device materials.

• Brand Name: 3 PEG PATELLA TRIAL 38MM
• 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: 12138993
• Report Number: 1038671-2021-00331
• Device Sequence Number: 4428612
• Product Code: JWH
• UDI-Device Identifier: 10885862041777
• UDI-Public: 10885862041777
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2022

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: 3 PEG PATELLA TRIAL 38MM
• Device Catalogue Number: 201-02-38
• Device Lot Number: 14308010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 10/25/2021; 01/24/2022
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 11/10/2021; 02/10/2022
• 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 Sex: Female