MAUDE Adverse Event Report: TORNIER INC. PRIMUS FLEXIBLE GREAT TOE IMPLANT, SIZE 30; NONE

Catalog Number FGT-30

Device Problem Malposition of Device (2616)

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

Event Type  malfunction  

Event Description

The implant appears to have subsided/shifted "plantarly" in the toe.

Manufacturer Narrative

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

Manufacturer Narrative

Repeated attempts made to surgeon and complaint reporter to obtain x-rays and additional information about the case were unsuccessful.There appears to be no defect in the device or manufacturing of the product returned.Due to an inability to obtain an x-ray or additional patient information it is not possible to determine if the original implant was seated properly in the bone.Additionally, er were unable to obtain any additional information regarding bone density or other possible contributing factors from the surgeon.Without additional information the root cause of this issue cannot be determined.This is the final report submitted regarding this surgical event and medical device.

• Brand Name: PRIMUS FLEXIBLE GREAT TOE IMPLANT, SIZE 30
• Type of Device: NONE
• Manufacturer (Section D): TORNIER INC. ; bloomington MN
• Manufacturer (Section G): TORNIER INC. ; 10801 nesbitt ave., south ; bloomington MN 55437
• Manufacturer Contact: kevin smith ; 10801 nesbitt ave., south ; bloomington , MN 55437 ; 9524267643
• MDR Report Key: 4597357
• MDR Text Key: 5628418
• Report Number: 3004983210-2015-00003
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown,company representative,unk
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FGT-30
• Device Lot Number: CT0414140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention