MAUDE Adverse Event Report: EXACTECH, INC. 3 PEG PATELLA TRIAL 35MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	201-02-35
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending device return and investigation.
Event or Problem Description
As reported, during trialing with the 35mm patella trial, while removing the patella trial one of the patella pegs broke off inside the patient.The surgeon was able to remove the nub using a drill.This led to a surgical delay of about 5 minutes.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: the broken instrument reported was likely the result of numerous surgical uses and subsequent sterilization cycles over a 17-year timespan, which resulted in a fractured peg during removal.However, this cannot be confirmed as the device was not returned for evaluation.

• Brand Name: 3 PEG PATELLA TRIAL 35MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15883540
• Report Number: 1038671-2022-01529
• Device Sequence Number: 14722094
• Product Code: JWH
• UDI-Device Identifier: 10885862041760
• UDI-Public: 10885862041760
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

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: 201-02-35
• Device Catalogue Number: 201-02-35
• Device Lot Number: 8225-3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/09/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 03/03/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male