MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. AM PLANTAR CANNULA; SMALL JOINT INSTRUMENT

Catalog Number AM330002

Device Problem Bent (1059)

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

Event Date 10/15/2014

Event Type  malfunction  

Event Description

Allegedly, the instrument bent during a surgical procedure.The sales representative was present at the surgery and a back up device was available.The surgery was delayed more than 30 minutes.

Manufacturer Narrative

The investigation is not yet complete.Trends will be evaluated, this report will be updated when the investigation is complete.

Manufacturer Narrative

Visual inspection of the returned parts shows that the walls of the shaft of the cannula have warped along the opening.Analysis of the returned devices indicates that the device was a contributor to the reported event.Based on analysis, a definitive root cause could not be determined.However the most likely root cause was due to external stresses applied to the cannula.

• Brand Name: AM PLANTAR CANNULA
• Type of Device: SMALL JOINT INSTRUMENT
• 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: amanda clark ; 1023 cherry road; memphis, TN 38117 ; 9018674140
• MDR Report Key: 4264896
• MDR Text Key: 5035206
• Report Number: 1043534-2014-00162
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,hea
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: AM330002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other