MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2004-09-20 for CAPTIVE HEX SCREWDRIVER ET 1052-01 manufactured by Endius, Inc..
[34743901]
A captive hextip screwdriver broke while the surgeon was tightening the last cap screw of a spinal fixation system. The surgeon attempted to remove the hex tip from the cap screw unsuccessfully. The tip of the screwdriver remained embedded in the capscrew and the patient was closed. The screwdriver is manufactured with 440c stainless steel but has not been used for implants. The capscrew is made from titanium. There is a possibility of interaction/corrosion due to the implantation of these dissimilar metals.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057469-2004-00005 |
| MDR Report Key | 5303354 |
| Report Source | DISTRIBUTOR |
| Date Received | 2004-09-20 |
| Date of Report | 2004-09-17 |
| Date of Event | 2004-08-25 |
| Date Mfgr Received | 2004-08-25 |
| Device Manufacturer Date | 2002-12-01 |
| Date Added to Maude | 2015-12-16 |
| 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 | CHRISTINE KUNTZ-NASSIF |
| Manufacturer Street | 23 WEST BACON ST. |
| Manufacturer City | PLAINVILLE MA 02762 |
| Manufacturer Country | US |
| Manufacturer Postal | 02762 |
| Manufacturer Phone | 5086430983 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAPTIVE HEX SCREWDRIVER |
| Generic Name | SCREWDRIVER |
| Product Code | LRZ |
| Date Received | 2004-09-20 |
| Returned To Mfg | 2004-09-08 |
| Model Number | NA |
| Catalog Number | ET 1052-01 |
| Lot Number | L526718 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDIUS, INC. |
| Manufacturer Address | PLAINVILLE MA 02762 US 02762 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-20 |