MAUDE Adverse Event Report: TORNIER INC. FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT INSTRUMENT; PROSTHESIS, TOE, CONSTRAINED, POLYMER

Catalog Number FGT-IMP

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/16/2015

Event Type  No Answer Provided  

Manufacturer Narrative

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

Event Description

It was reported that: "doctor went to impact the grommet.Tip of the impactor broke off into the patient bone.The planter portion of the metatarsal broke as well.(technique was followed exactly)."doctor went to impact the grommet.Tip of the impactor broke off into the patient bone.The planter portion of the metatarsal broke as well.(technique was followed exactly).It delayed surgery and doctor had to do a different procedure.After following proper technique of cutting and broaching for the primus great toe implant, dr.(b)(6) digitally inserted the grommets in the bone ends and inserted the implant.After cycling the joint a few times, the grommets were seen to not be seated and falling out.I suggested using the "grommet impactor" from the tornier tray to fully seat the grommets.I also suggested not using the grommets as they are not required.Dr.(b)(6) removed the primus implant and preceded to forcefully mallet the "grommet impactor" into the metatarsal side.The tip of the impactor broke off inside the grommet and patient's bone.The broken piece was able to be removed.Dr.(b)(6) then noticed he fractured a large piece of plantar bone from the metatarsal.Because of this fracture, the grommet and implant would not hold in place and could not be utilized.Dr.(b)(6) could no longer complete this procedure.At this point, the patient was left with a large void at the joint." no further patient complications have been reported in relation to this event.

• Brand Name: FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT INSTRUMENT
• Type of Device: PROSTHESIS, TOE, CONSTRAINED, POLYMER
• Manufacturer (Section D): TORNIER INC.; 10801 nesbit avenue south; bloomington MN 55437
• Manufacturer Contact: dustin smith ; 10801 nesbit ave south; bloomington, MN 55437 ; 9529217121
• MDR Report Key: 5342003
• MDR Text Key: 34986178
• Report Number: 3004983210-2015-00084
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: FGT-IMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR