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	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that " the procedure for the placement of the ankle prosthesis was standard until we wanted to put the pin sleeves in the holes of the distal part of the alignment jig.Impossible to put the 2 sleeves in 2 holes of the guide.Even less possible to put 2 sockets in the axis as required by the operating technique.We have tried everything to avoid the handling error, without success.We tried to find a solution to adapt, but found no alternative to continue the procedure.The event was discovered during the placement of the sleeves in the alignment jig holes as mentioned above.Steps/actions taken to complete the procedure: the surgeon made the decision to perform an ankle plate arthrodesis.The duration of the procedure was therefore longer than a conventional plate arthrodesis.".
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: visual examination of the returned device shows slight blemishes on the inner part of the guide holes.However, no significant deformations are visible.A functional test was performed using a pin sleeve with the same part number and a different lot number as those referenced in the reported event.The pin sleeve was able to pass through the proximal holes of the device but failed to fully fit through the distal holes as reported.Gage pins were used to verify the dimensions of the distal holes of the device.A 0.232862 minus pin and a 0.232519 plus pin were used to perform the dimensional inspection.Both pins were unable to fit through the distal holes of the device.Therefore, the distal holes of the device were confirmed to be out of dimensional specification.Based on investigation, the root cause was attributed to a manufacturing/supplier related issue.A nonconformance was opened to further investigate the issue.
Event or Problem Description
It was reported that " the procedure for the placement of the ankle prosthesis was standard until we wanted to put the pin sleeves in the holes of the distal part of the alignment jig.Impossible to put the 2 sleeves in 2 holes of the guide.Even less possible to put 2 sockets in the axis as required by the operating technique.We have tried everything to avoid the handling error, without success.We tried to find a solution to adapt, but found no alternative to continue the procedure.The event was discovered during the placement of the sleeves in the alignment jig holes as mentioned above.Steps/actions taken to complete the procedure: the surgeon made the decision to perform an ankle plate arthrodesis.The duration of the procedure was therefore longer than a conventional plate arthrodesis.".
Additional Manufacturer Narrative
Correction: b1, h1.

• 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: 16631680
• Report Number: 3010667733-2023-00156
• Device Sequence Number: 20150807
• Product Code: HSN
• UDI-Device Identifier: 00889797003926
• UDI-Public: 00889797003926
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 05/07/2024

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?: 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: 01/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 05/07/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown