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

Model Number VANTAGE TBL RADEL IMPCTR

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event 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.

• Brand Name: VANTAGE TBL RADEL IMPCTR
• Type of Device: 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
• MDR Text Key: 327023044
• Report Number: 1038671-2023-02645
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862532282
• UDI-Public: 10885862532282
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K152217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VANTAGE TBL RADEL IMPCTR
• Device Catalogue Number: 351-17-02
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1