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	05/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during impaction of then talar implant, the talar implant inserter broke.No parts or pieces fell into the patients wound site.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Device is returning.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
The broken talar impactor cover reported was likely the result of additional stresses on the retaining tabs during impaction due to minimal joint space in a mobile bearing, which led to crack initiation, propagation, and ultimate fracture of the device.

• 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: 14521104
• Report Number: 1038671-2022-00622
• Device Sequence Number: 6428549
• Product Code: LXH
• UDI-Device Identifier: 10885862563415
• UDI-Public: 10885862563415
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/26/2022

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: 351-07-04
• Device Catalogue Number: 351-07-04
• Device Lot Number: 145714002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 08/26/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown