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	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was impacting the talus and when he went to mallet, the black tip of the talus impactor broke off.The tiny piece that broke off the tip was discarded in the or but i was able to keep the main portion of the black tip off the talus impactor.Patient was not affected by this.Patient not affected by this.There was no surgical delay/prolongation.No parts or pieces fell into the patient wound site.Device to be returned.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
Section h10: (h3) 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.Section h11: *the following sections have corrected information: (h6) component code: 4733, connector/coupler.

• 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: 14012946
• Report Number: 1038671-2022-00368
• Device Sequence Number: 20239569
• Product Code: LXH
• UDI-Device Identifier: 10885862563415
• UDI-Public: 10885862563415
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 08/31/2022

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: 03/16/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 08/31/2022
• 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