MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. SWANSON FINGER; SMALL JOINT COMPONENT

Catalog Number 470000X

Device Problem Material Rupture (1546)

Patient Problem Failure of Implant (1924)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

The investigation is not complete.Trends will be evaluated.This report will be updated when the investigation is complete.This event occurred in (b)(6).

Event Description

Allegedly, pip implant rupture joint forefinger.Laxity ---> implant exchange.Prostheses exchange stabilization op.

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: SWANSON FINGER
• 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: 5983162
• MDR Text Key: 55809310
• Report Number: 1043534-2016-00111
• Device Sequence Number: 1
• Product Code: KWF
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 470000X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/15/2016
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention