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

Catalog Number	351-07-04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during surgery/impact, the surgeon used the talar impactor as recommended and realized the insert broke at one of the sides while impacting final talar implant.No other patient information reported.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
The fractured vantage lp impactor insert reported was likely the result of a stress riser introduced during impaction 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: 12913502
• Report Number: 1038671-2021-00653
• Device Sequence Number: 5085807
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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 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: 11/11/2021
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 03/02/2022
• 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: Required Intervention
• Patient Sex: Unknown