MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; LP TALAR IMPACTOR INSERT

Model Number	351-07-04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: pending evaluation, "no information provided.".
Event or Problem Description
It was reported that during impaction, the joint was very stiff and the surgeon had to hit the talar impactor very hard to push the final implant in.When the first talar impactor plastic protection broke, we had another on that was onsite to use but it broke as well.After removing the broken piece and cleaning out the patient, we could still use the talar impactor plastic protection to complete the surgery with no further complications.There was a small surgical delay that was less than 5 minutes.The patient did not experience any adverse event as a result of the surgical delay/ prolongation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) the broken talar impactor cover reported was likely the result of the material not being designed to properly withstand the stresses experienced during use which led to ultimate fracture of the devices.

• Brand Name: VANTAGE
• Common Device Name: LP TALAR IMPACTOR INSERT
• 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: 14140501
• Report Number: 1038671-2022-00427
• Device Sequence Number: 11762562
• Product Code: HSN
• UDI-Device Identifier: 10885862563415
• UDI-Public: 10885862563415
• Combination Product (Y/N): N
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 351-07-04
• Device Catalogue Number: 351-07-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 11/23/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown