MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-02-07 for CORE IMPACTION DRILL 5400300000 manufactured by Stryker Instruments-kalamazoo.
[4093520]
It was reported that during testing conducted at the user facility the core impaction drill was overheating. No medical intervention and no adverse consequences were reported with this event. As this event occurred during testing at the user facility, there was no patient involvement and no delay to a surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
[11660254]
Upon disassembly for visual inspection corrosion was found within the device, the motor pins were damaged, a bearing was stuck on the rotor, the driveshaft was sticking, and the rotor coupler and spindle housing were worn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2014-00394 |
| MDR Report Key | 3612555 |
| Report Source | 06 |
| Date Received | 2014-02-07 |
| Date of Report | 2014-01-13 |
| Date of Event | 2014-01-09 |
| Date Mfgr Received | 2014-01-13 |
| Device Manufacturer Date | 2005-11-16 |
| Date Added to Maude | 2014-04-30 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. CASEY METZGER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORE IMPACTION DRILL |
| Generic Name | DRIVER, WIRE, AND BONE DRILL, MANUAL |
| Product Code | DZK |
| Date Received | 2014-02-07 |
| Returned To Mfg | 2014-01-23 |
| Catalog Number | 5400300000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-07 |