MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-05-21 for LOANER TPS MICRODRIVER 5100088000L manufactured by Stryker Instruments-kalamazoo.
[5807700]
The loaner tps microdriver was returned to stryker instruments for service. During functional testing by a service technician, it was found that the device was able to run in safe mode. No medical intervention and no adverse consequences were reported with this event. As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
[13374350]
The failure for running in safe mode was confirmed through functional testing, disassembly, and visual inspection. The trigger assembly was worn. The device was repaired and placed back into stryker stock.
Patient Sequence No: 1, Text Type: N, H10
[19601550]
The loaner tps microdriver was returned to stryker instruments for service. During functional testing by a service technician, it was found that the device was able to run in safe mode. No medical intervention and no adverse consequences were reported with this event. As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2015-01829 |
| MDR Report Key | 4787061 |
| Report Source | 07 |
| Date Received | 2015-05-21 |
| Date of Report | 2015-04-23 |
| Date of Event | 2015-04-23 |
| Date Mfgr Received | 2015-06-15 |
| Device Manufacturer Date | 1999-01-21 |
| Date Added to Maude | 2015-05-21 |
| 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 | 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 | LOANER TPS MICRODRIVER |
| Generic Name | DRIVER, WIRE, AND BONE DRILL, MANUAL |
| Product Code | DZJ |
| Date Received | 2015-05-21 |
| Returned To Mfg | 2015-04-18 |
| Catalog Number | 5100088000L |
| Operator | OTHER |
| 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 | 2015-05-21 |