MAUDE Adverse Event Report: TORNIER INC.,

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 07/18/2014

Event Type  No Answer Provided  

Event Description

Surgeon implanted the trial instead of the implant.Nurse noticed that the implant was not implanted after the case and they left the trial in after the pt was closed.The doctor was not concerned and said the trial was sterile so they left the trial in the pt.Hosp called and asked what material makes up the trial that was left in the pt.

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.

• Brand Name: UNK
• Type of Device: UNK
• Manufacturer (Section D): TORNIER INC.,; bloomington MN
• Manufacturer (Section G): TORNIER INC.,; 10801 nesbitt ave s; bloomington MN 55437
• Manufacturer Contact: kevin smith ; 10801 nesbitt ave s; bloomington, MN 55437 ; 9524267643
• MDR Report Key: 4131222
• MDR Text Key: 4922070
• Report Number: 3004983210-2014-00019
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1