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	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
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: the middle distal hole of the instrument can be seen to be deformed.Aside from this deformation, no other significant damages can be found around the instrument.Two pin sleeves were returned and used to perform the functional test.The pin sleeves could not fit through the three distal holes but were able to pass through the three proximal holes of the instrument.A 0.233 minus gage pin was used to verify the dimensions of the holes.The gage pin was unable to fit through all six holes of the instrument confirming the instrument was not manufactured to specification.Based on investigation, the root cause was attributed to a manufacturing related issue.A nonconformance was opened to further address the issue.
Event or Problem Description
It was reported that the pin could not be inserted into the center hold of the alignment frame guide.Medical procedure was completed by pushing pin sleeve to end of hole.

• 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: 16979857
• Report Number: 3010667733-2023-00267
• Device Sequence Number: 2453262
• Product Code: HSN
• UDI-Device Identifier: 00889797003926
• UDI-Public: 00889797003926
• 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: Physician
• 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: 03/30/2023
• Is the Reporter a Health Professional?: Yes
• 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