MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-05-15 for TPS MICRO DRIVER 5100088000 manufactured by Stryker Instruments-kalamazoo.
[21474369]
It was reported that during set up, by the customer at the user facility, when putting the tps micro driver in forward or safe, the handpiece would run in reverse. When putting into reverse, the handpiece would not run at all. As this event occurred during set up at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[25570961]
The reported event of running in safe and not running in reverse was duplicated by the service technician. Through visual inspection, the technician observed widespread corrosion in the device.
Patient Sequence No: 1, Text Type: N, H10
[25570962]
It was reported that during set up, by the customer at the user facility, when putting the tps micro driver in forward or safe, the handpiece would run in reverse. When putting into reverse, the handpiece would not run at all. As this event occurred during set up at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2015-01766 |
| MDR Report Key | 4773844 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-05-15 |
| Date of Report | 2015-04-21 |
| Date of Event | 2015-04-20 |
| Date Mfgr Received | 2015-09-10 |
| Device Manufacturer Date | 2000-04-09 |
| Date Added to Maude | 2015-05-15 |
| 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 | 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 | TPS MICRO DRIVER |
| Generic Name | DRIVER, WIRE, AND BONE DRILL, MANUAL |
| Product Code | DZJ |
| Date Received | 2015-05-15 |
| Returned To Mfg | 2015-04-28 |
| Catalog Number | 5100088000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2015-05-15 |