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

Catalog Number 350-10-02

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 10/11/2023

Event Type  Injury  

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 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.

• Brand Name: ANKLE SZ 2 LOCKING CLIP
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18060431
• MDR Text Key: 327248367
• Report Number: 1038671-2023-02665
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862302007
• UDI-Public: 10885862302007
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 350-10-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 56 YR
• Patient Sex: Female