MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE ANKLE COMPONENTS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	SOLID SCREWDRIVER SZ T15
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during surgery on (b)(6) 2024, one of the t-15 driver¿s tip broke off in the screw.It is believed this was caused due to the surgeon trying to remove a locking screw with power and it slipped and snapped off.The tip was then embedded in the screw but it came off and another t-15 driver was used and the case was continued.There were no other issues during the case.This event is not associated with a revision of exactech implants.All fragments, parts and pieces were removed from the patient wound site.Sales rep was unable to obtain photos/x-rays.The device is not available for evaluation due to it was thrown out after the case.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d1, d2a, d2b, d4, d6b, g1, h5, h6 - health effect - clinical code, health effect - impact code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusions.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A review of manufacturing data was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial taa of an unknown side on an unknown date.Subsequently, it was reported that the patient underwent a revision of the talar component and polyethylene liner for an unknown reason.No further patient impact reported.No further information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: g1, h6 - medical device problem code, type of investigation and h11.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: VANTAGE ANKLE COMPONENTS
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 19037906
• Report Number: 1038671-2024-00731
• Device Sequence Number: 8188081
• Product Code: HSN
• UDI-Device Identifier: 00817577022768
• UDI-Public: 00817577022768
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2026

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: SOLID SCREWDRIVER SZ T15
• Device Catalogue Number: 2100-0015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 07/18/2025; 04/13/2026
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 07/23/2025; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Female