MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-13 for QUICKDRIVE BATTERY POWERED SCREWDRIVER MINI * 62-50101 manufactured by Stryker Leibinger Freiburg.
[16267630]
The qdm would "run-on", after being turned off. A "run-on" occurence could lead to an injury in future cases and is considered a malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010177-2006-00029 |
| MDR Report Key | 740464 |
| Date Received | 2006-07-13 |
| Date of Report | 2006-06-15 |
| Date of Event | 2006-06-13 |
| Date Mfgr Received | 2006-06-15 |
| Date Added to Maude | 2006-07-27 |
| 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 | 0 |
| Manufacturer Contact | TENNILLE FOLK |
| Manufacturer Street | 750 TRADE CENTRE WAY SUITE 200 |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693245346 |
| Manufacturer G1 | STRYKER LEIBINGER FREIBURG |
| Manufacturer Street | BOTZINGER STRASSE 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICKDRIVE BATTERY POWERED SCREWDRIVER MINI |
| Generic Name | INSTRUMENT |
| Product Code | HXY |
| Date Received | 2006-07-13 |
| Model Number | * |
| Catalog Number | 62-50101 |
| Lot Number | G6200F9999-SN 0038 |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 728334 |
| Manufacturer | STRYKER LEIBINGER FREIBURG |
| Manufacturer Address | * FREIBURG GM D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-13 |