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 2015-06-22 for TPS MICRO DRIVER 5100088000 manufactured by Stryker Instruments-kalamazoo.
[5851920]
It was reported that during sterilization at the user facility, the trigger of the tps micro driver is sticking. As this event occurred during testing 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
[25949119]
The reported event of sticking trigger was duplicated. Through visual evaluation, the technician observed both a non-stryker gasket and non-stryker motor. Disassembly of the device revealed both wear and corrosion on the trigger shaft. The trigger assembly and non-conforming parts were replaced, device passed final inspection, and was returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
[25949120]
It was reported that during sterilization at the user facility, the trigger of the tps micro driver is sticking. As this event occurred during testing 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 | 0001811755-2015-02249 |
| MDR Report Key | 4858423 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-06-22 |
| Date of Report | 2015-06-01 |
| Date of Event | 2015-06-01 |
| Date Mfgr Received | 2015-09-16 |
| Device Manufacturer Date | 2005-03-04 |
| Date Added to Maude | 2015-06-22 |
| 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 | 2015-06-22 |
| Returned To Mfg | 2015-06-05 |
| Catalog Number | 5100088000 |
| 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 | 2015-06-22 |