MAUDE Adverse Event Report: EXACTECH, INC. TALAR TRIAL SCREW; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	351-90-04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Event or Problem Description
It was reported that during surgical use the experienced surgical team faced a breakage of the screw.No sclerotic bone was detected.No parts remained in situ.The broken part of the screw remained in the talus.There was a 5 minute delay.Patient was last known to be in stable condition following the event.No other patient information provided.Product not returning - broken part was disposed after surgery.
Additional Manufacturer Narrative
Section h10: (h3) the broken talar screw reported may have been the result of the application of a bending moment during surgical use, allowing it to fracture.This cannot be confirmed; however, because the device was not returned for evaluation.Section h11: *the following sections have corrected information: (h6) component code: 568, screw.

• Brand Name: TALAR TRIAL SCREW
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson kate jacobson ; 3523771140
• MDR Report Key: 17255576
• Report Number: 1038671-2023-01531
• Device Sequence Number: 7912015
• Product Code: HSN
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 351-90-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 09/01/2023; 04/29/2026
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 09/20/2023; 05/27/2026
• 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