MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-01-04 for FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT INSTRUMENT FGT-IMP manufactured by Tornier Inc..
[34986178]
This is the final report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
[34986179]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004983210-2015-00084 |
| MDR Report Key | 5342003 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-01-04 |
| Date of Report | 2015-12-21 |
| Date of Event | 2015-09-16 |
| Date Mfgr Received | 2015-12-21 |
| Date Added to Maude | 2016-01-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DUSTIN SMITH |
| Manufacturer Street | 10801 NESBIT AVE SOUTH |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal | 55437 |
| Manufacturer Phone | 9529217121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT INSTRUMENT |
| Generic Name | PROSTHESIS, TOE, CONSTRAINED, POLYMER |
| Product Code | KWH |
| Date Received | 2016-01-04 |
| Catalog Number | FGT-IMP |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC. |
| Manufacturer Address | 10801 NESBIT AVENUE SOUTH BLOOMINGTON MN 55437 US 55437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-01-04 |