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

Model Number 201-02-35

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

Pending device return and investigation.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 304505417
• Report Number: 1038671-2022-01529
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862041760
• UDI-Public: 10885862041760
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 11/29/2022
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male