MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY(R) TALAR DOME SZ 3; SMALL JOINT COMPONENT

Catalog Number 3363-0023

Device Problem Hole In Material (1293)

Patient Problem No Code Available (3191)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

The investigation is not complete.This report will be updated when the investigation is complete.Trends will be evaluated.This is the same event as 1043534-2016-00047, 00049.

Event Description

Allegedly, the guides fit well and the pins for placing the metal cut guides were in the appropriate position according to the preoperative report.However, when making the cuts to the tibia a very large void in the distal tibia was noted.This void was not identified in the preoperative report.

Manufacturer Narrative

This incident is considered closed.If at any time new or updated information becomes available, the incident will be re-opened and investigated.

• Brand Name: INFINITY(R) TALAR DOME SZ 3
• 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 ; 901451-631
• MDR Report Key: 5746820
• MDR Text Key: 48098008
• Report Number: 1043534-2016-00048
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2016

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?: No
• Device Operator: Other
• Device Catalogue Number: 3363-0023
• Device Lot Number: 1572872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 06/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1