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

Model Number	33600020
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: slight scratches and blemishes can be seen within the inner holes of the instrument.However, no significant deformations are visible.A pin sleeve with the same part number as the one referenced in the reported event was used to perform the functional test.The pin sleeve could fit through all three distal holes of the instrument but could not pass through two of the proximal holes.A 0.233 minus gage pin was used to verify the dimensions of the holes.The gage pin could not fit through all six holes of the instrument confirming the device was not manufactured to specification.Based on investigation, the root cause was attributed to a manufacturing related issue.A nonconformance was opened to further investigate the issue.
Event or Problem Description
It was reported that the sleeve did not pass through the guide arm.

• Brand Name: ALIGNMENT FRAME DIST 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16979594
• Report Number: 3010667733-2023-00266
• Device Sequence Number: 14089170
• Product Code: HSN
• UDI-Device Identifier: 00889797003926
• UDI-Public: 00889797003926
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2023

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 Model Number: 33600020
• Device Catalogue Number: 33600020
• Device Lot Number: 2656815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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