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

Model Number	VANTAGE TBL RADEL IMPCTR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the loaner equipment was returned to exactech uk office after use during surgical procedure and rep became aware of the impactor being broken.The case was not covered by an exactech rep,; therefore, sales rep could not ascertain the events leading up to the breakage.There was no surgical delay/prolongation.Patient last known to be in stable condition following event.The device will be return.No further information.
Additional Manufacturer Narrative
H3: the broken mobile bearing tibial radel impactor reported was likely the result of a stress riser introduced while impacting the tibial component into the bone, which led to crack initiation, propagation, and ultimate fracture of the radel surface.

• Brand Name: VANTAGE TBL RADEL IMPCTR
• 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: kate jacobson
• MDR Report Key: 18044403
• Report Number: 1038671-2023-02645
• Device Sequence Number: 7465895
• Product Code: HSN
• UDI-Device Identifier: 10885862532282
• UDI-Public: 10885862532282
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: VANTAGE TBL RADEL IMPCTR
• Device Catalogue Number: 351-17-02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 06/11/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown