MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33600030

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

The resection guide adjustment block screw that locks the proximal/distal adjustment could not be turned.The screw would only turn 2mm each way meaning that the proximal/distal height of the block was unable to be locked into place.The resection block was required and the surgeon was unable to lock out the proximal/distal adjustment.The surgeon decided to carefully proceed with the case, ensuring that the proximal distal (purple adjustment knob) was not disturbed whilst x4 2.4 steinmann pins were installed.Approximately 30 mins was added to tourniquet time in order that the block could be removed and an attempt to fix problem with screw.As adjustment block was removed once resection height had already been decided under fluoroscopy, the whole imaging process had to be started again to ensure that the block had not moved prior to installing pins.

• Brand Name: INFINITY TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, TN 38117
• MDR Report Key: 8812950
• MDR Text Key: 151769585
• Report Number: 1043534-2019-00074
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2019

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
• Device Operator: Health Professional
• Device Model Number: 33600030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1