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

Model Number	351-90-04
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during surgical use, the surgeon faced a flattened and hard bone.While placing the talar trial it was noticed that the talar trial showed non-optimal positioning.After repositioning the talar trial, the surgeon had to use more force to screw it in.While screwing it in, the screw broke.The surgeon decided not to remove the screw to prevent the bone from further damage after two attempts of setting the screw.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H3: the broken talar trial screw reported may have been the result of applying a bending moment while drilling into the talus, allowing it to fracture.However, this cannot be confirmed as the device was not returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16885688
• Report Number: 1038671-2023-00922
• Device Sequence Number: 6174207
• Product Code: HSN
• UDI-Device Identifier: 10885862301505
• UDI-Public: 10885862301505
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2026

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
• Device Model Number: 351-90-04
• Device Catalogue Number: 351-90-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 07/13/2023; 01/27/2026
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 07/25/2023; 02/09/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown