MAUDE Adverse Event Report: EXACTECH, INC. ANKLE SZ 2 LOCKING CLIP; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	350-10-02
Medical Device Problem Codes	Fracture (1260); Structural Problem (2506)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): (b)(6) 350-21-12 - tibial insert fb sz 2 lt 7mm.(b)(6) 350-03-02 - flat cut talus sz 2 l.(b)(6) 351-90-22 - 2.5" pin pouch.(b)(6) 351-90-24 - talar trial screw pouch.(b)(6) 350-11-02 - tibial plate fb sz 2 lt.(b)(6) 351-90-21 - 3.5" pin pouch.(b)(6) 351-90-21 - 3.5" pin pouch.(b)(6) 351-90-20 - tubercle pin pouch.
Event or Problem Description
As reported, approximately 2.5 years post op initial left ankle replacement, this 56 y/o female patient was revised due the locking clip disassociated from tibial tray.Clip broke in situ.Surgeon swapped out clip & poly.Patient was last known to be in stable condition following the event.No images or x-rays available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of the locking clip not being fully engaged at the time of initial surgery, allowing the locking clip to fracture and disengage from the tibial plate over time.However, this cannot be confirmed as images, radiographs, or relevant clinical information were not provided.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.D4: corrected.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: ANKLE SZ 2 LOCKING CLIP
• 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: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18060431
• Report Number: 1038671-2023-02665
• Device Sequence Number: 6628964
• Product Code: HSN
• UDI-Device Identifier: 10885862302007
• UDI-Public: 10885862302007
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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: 350-10-02
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2020
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 56 YR
• Patient Sex: Female