MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-09-20 for INDUS INVUE SOLID TIPPED DRIVER 11-70083 manufactured by Spinefrontier.
[2890222]
During surgery to implant indus invue anterior cervical plate system, the surgeon was inserting screws that hold the plates in place. The tip to the driver broke off inside the screw. The broken driver tip was removed, and another was used to insert the remaining screws successfully. The surgery was completed and no harm was caused to the patient. This instrument malfunction does impair the ability of the surgeon to successfully complete the implantation of the indus invue anterior cervical plate system and could possibly lead to an extension of time in surgery had there not been another driver available.
Patient Sequence No: 1, Text Type: D, B5
[10141183]
This report is identical to 3005977257-2012-00004. The issue with the indus invue solid tipped driver with this report is similar to the issue in mdrs 3005977257-2012-00001, and -00002, with exception that the tip breaking off of the driver does present a more substantial risk to the patient than in the two above mentioned cases. This risk necessitates the filing of a medical device report. The issue with these drivers was that initially the tips were too long and interfered with their ability to insert screws during surgery. This design was revised with a shorter tip to avoid the interference, but these were the ones that started to break, as in the case of this report. The next two revisions were designed with the tips that fit better with various sized screws, and the problem was mitigated. The driver in this case was returned and visually inspected by the engineering and design team who were able to conclude that the tip length was the issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005977257-2012-00003 |
| MDR Report Key | 2761572 |
| Report Source | 07 |
| Date Received | 2012-09-20 |
| Date of Report | 2012-09-12 |
| Date of Event | 2012-04-24 |
| Date Mfgr Received | 2012-04-24 |
| Date Added to Maude | 2013-01-10 |
| 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 SUITE 3500 |
| Manufacturer City | BEVERLY MA 01915 |
| Manufacturer Country | US |
| Manufacturer Postal | 01915 |
| Manufacturer Phone | 9782323990 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDUS INVUE SOLID TIPPED DRIVER |
| Generic Name | SOLID TIPPED DRIVER |
| Product Code | MRW |
| Date Received | 2012-09-20 |
| Model Number | 11-70083 |
| Lot Number | 011836-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINEFRONTIER |
| Manufacturer Address | 500 CUMMINGS CENTER SUITE 3500 BEVERLY MA 01915 US 01915 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-20 |