MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-03-20 for FACETFUSE CANNULATED DRILL SI00214 manufactured by Spinefrontier.
[3318087]
A full audit of all legacy complaints since the inception of the company (2007) was conducted to assure any non-conformities that may exist from earlier years were discovered and properly documented and addressed. During the audit this reportable event was identified and is now being submitted. Previous personnel had deemed this a non-reportable. This event was to be reported within 30 days of occurring. While drilling into the facet joint for implantation of facetfuse system, the surgeon drastically changed the angle of the facetfuse drill. This caused the drill to break at the top of the flutes. The surgeon was able to use other instrumentation to safely remove the drill bit from the pt.
Patient Sequence No: 1, Text Type: D, B5
[10588912]
F/u with field rep revealed that the surgeon drastically changed the angle of the drill while drilling. This excessive force resulted in the drill breaking. Lot history was reviewed and found to be in compliance with quality requirement. The facetfuse surgical technique includes the note to check to maintain trajectory while drilling to prevent hole over sizing from severe trajectory adjustment. Although this reference was in regards to hole over sizing, the surgical technique has since been updated to include cautionary note specifically for change of drill trajectory while drilling. See scanned pages.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005977257-2013-00005 |
| MDR Report Key | 3020981 |
| Report Source | 07 |
| Date Received | 2013-03-20 |
| Date of Report | 2013-03-13 |
| Date of Event | 2011-09-21 |
| Date Mfgr Received | 2011-09-21 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2013-05-22 |
| 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 | NICOLE BAGINSKI |
| Manufacturer Street | 500 CUMMINGS CENTER STE 3500 |
| Manufacturer City | BEVERLY MA 01915 |
| Manufacturer Country | US |
| Manufacturer Postal | 01915 |
| Manufacturer Phone | 9782323990 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FACETFUSE CANNULATED DRILL |
| Generic Name | CANNULATED DRILL |
| Product Code | MRW |
| Date Received | 2013-03-20 |
| Model Number | SI00214 |
| Lot Number | R75H12812 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINEFRONTIER |
| Manufacturer Address | 500 CUMMINGS CENTER STE 3500 BEVERLY MA 01915 US 01915 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-20 |