MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TIBIAL PLATE FB SZ 1 LT

Model Number	350-11-01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.No information provided in the following section(s).
Event or Problem Description
It was reported that during impaction of the left ankle, the surgeon was trying to further seat the tibial just a bit more after already impacting it several times and a small part of the rim of the implant where the poly inserts into broke off.This prevented a trial poly from being placed in the component and ultimately the surgeon took that tibial tray out and put a new one in its place.There was no surgical delay.Patient was last known to be in stable condition following the event.No other patient information or medical history was reported.Devices will be returning.
Additional Manufacturer Narrative
Pending evaluation.No information provided in the following section(s).
Event or Problem Description
It was reported that during impaction of the left ankle, the surgeon was trying to further seat the tibial just a bit more after already impacting it several times and a small part of the rim of the implant where the poly inserts into broke off.This prevented a trial poly from being placed in the component and ultimately the surgeon took that tibial tray out and put a new one in its place.There was no surgical delay.Patient was last known to be in stable condition following the event.No other patient information or medical history was reported.Devices will be returning.
Additional Manufacturer Narrative
Section h10: (h3) the prosthesis fracture reported was likely the result of not using the tibial protector as instructed in the operative technique when impacting the tibial plate.

• Brand Name: VANTAGE
• Common Device Name: TIBIAL PLATE FB SZ 1 LT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 13290666
• Report Number: 1038671-2022-00030
• Device Sequence Number: 11864385
• Product Code: HSN
• UDI-Device Identifier: 10885862276131
• UDI-Public: 10885862276131
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 350-11-01
• Device Catalogue Number: 350-11-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female