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

Model Number 33600030

Device Problem Device Inoperable (1663)

Patient Problem Visual Disturbances (2140)

Event Date 07/18/2017

Event Type  Injury  

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

It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the adjustment block screw was lodged in adjustment block and could not be backed out to lock into the coronal guide.The surgeon postponed the case after the patient was already put under anesthesia.No additional patient complications were reported.

Manufacturer Narrative

Visual examination of the returned part does not show any overall gross deformation.Upon an initial functional review of the devices, some of the lock outs seemed jammed but were able to be released without any additional aid of lubrication and/or power, and then the adjustment block knobs functioned as intended.Also, the functional evaluation included a review of the coronal guide lockout, in which a coronal guide was able to be locked into place.Therefore, no failure was detected.

• Brand Name: INFINITY®
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer Contact: matthew parrish ; 1023 cherry road; 901451-631
• MDR Report Key: 6793026
• MDR Text Key: 82653126
• Report Number: 1043534-2017-00084
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 33600030
• Device Lot Number: 1582249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/18/2017
• Event Location: Hospital
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other