MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC ALIGNMENT FRAME PROX SUB ASSEM INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33600021
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that "the 3.2 mm pin no longer fits through the designated pin hole in the frame.".
Additional Manufacturer Narrative
Correction to h3 (device evaluated by mfg).The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the received product shows that the received instrument is in good condition, except for the defective bore.By the entrance of the bore there is a cyrcle visible which is the result of working with a power-tool, most likely from the drill chuck that has come into contact with the instrument.Furthermore, it is clearly evident that foreign material has become lodged in the borehole.Functional examination of the received product shows that it was determined that the instrument is functional, except for the defective bore.All measurements taken are within accuracy, except for the defective bore.Based on the investigation, the damage is attributed to use.Material buildup was identified within the bore, likely resulting from extended operation at excessive rotational speed using a power tool.A manufacturing defect can be excluded.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a use related issue.The failure was caused most likely resulting from extended operation at excessive rotational speed using a power tool.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that "the 3.2 mm pin no longer fits through the designated pin hole in the frame.".

• Brand Name: ALIGNMENT FRAME PROX SUB ASSEM INFINITY TOTAL ANKLE SYSTEM
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24299345
• Report Number: 3010667733-2026-00097
• Device Sequence Number: 16047591
• Product Code: HSN
• UDI-Device Identifier: 00889797003933
• UDI-Public: (01)00889797003933(11)221122(10)2762126
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 33600021
• Device Lot Number: 2762126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown