MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY® RESECTION ADJUSTMENT BLOCK; SMALL JOINT COMPONENT

Catalog Number 33600030

Device Problems Mechanical Jam (2983); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 04/11/2015

Event Type  Injury  

Event Description

Allegedly, unable to turn the knob on the resection guide with the hex driver.Resection guide was jammed.Also, had difficulty getting the sagittal sizing guide onto the sagittal sizing guide ratcheting arm.The implantation site/procedure was a total ankle replacement.The issue was resolved by using pliers to turn the knob on resection guide into correct position.This issue lead to an extention in surgery time greater than 30 minutes.

Manufacturer Narrative

Nvestigation not complete.Product has not been returned.Trends will be evaluated.This report will be updated when the investigation is complete.This is the same event as 1043534-2015-00021.

• Brand Name: INFINITY® RESECTION ADJUSTMENT BLOCK
• Type of Device: SMALL JOINT COMPONENT
• 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: 1023 cherry road; memphis, TN 38117 ; 901867-414
• MDR Report Key: 4690686
• MDR Text Key: 5650091
• Report Number: 1043534-2015-00021
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K140749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 33600030
• Device Lot Number: 1333532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR