MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-10-31 for FACETFUSE DRILL 11-00032 manufactured by Spinefrontier.
[2939114]
Surgeon was performing a procedure with facetfuse mis screw system and was using the facetfuse drill bit (part number (b)(4)) to create pilot holes for placement of facetfuse screws. He was attempting to get the desired trajectory by leaning on the drill, which caused it to bend and break. The distal end of the drill bit remained in the inferior facet of l5 of the pt, while the proximal end remained in the drill assembly. The surgeon removed the inferior facet of l5 from the pt in order to remove the drill bit, and used an interspinous plate for fixation, instead of a facet screw. In total 20 minutes were added to the surgery, and no add'l blood was necessary. The surgery was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[10266353]
A review of the device history and lot history did not indicate any changes in the design or mfg that would contribute to the breaking of the bit. A review of the broken bit itself did not reveal any deficiencies that would contribute to the breaking of the bit. The facetfuse drill bit was subjected to a force that was great enough to cause the breakage. Surgeons that change the trajectory of a drill bit while drilling run the risk that the force being placed on it can cause it to break. In this case the surgeon was leaning down on the drill trying to get the desired trajectory, which caused the bit to bend and break. The facetfuse surgical technique has the warning "do not change trajectory of dill when drilling. If trajectory needs to be corrected remove drill completely and re-drill pilot hole. " this is on the same page as the step that demonstrates how to prepare the screw hole with the drill. Eval summary: facetfuse mis screw system surgical technique ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005977257-2012-00016 |
| MDR Report Key | 2820301 |
| Report Source | 07 |
| Date Received | 2012-10-31 |
| Date of Report | 2012-10-31 |
| Date of Event | 2012-10-01 |
| Date Mfgr Received | 2012-10-01 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2013-02-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 500 CUMMINGS CENTER STE 3500 |
| Manufacturer City | BEVERLY MA 01915 |
| Manufacturer Country | US |
| Manufacturer Postal | 01915 |
| Manufacturer Phone | 9782323990 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FACETFUSE DRILL |
| Generic Name | DRILL, SOLID, 03.5MM X 50MM |
| Product Code | MRW |
| Date Received | 2012-10-31 |
| Returned To Mfg | 2012-10-03 |
| Model Number | 11-00032 |
| Lot Number | 30307 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINEFRONTIER |
| Manufacturer Address | BEVERLY MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-10-31 |