MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-03-11 for TPS MICRO DRIVER 5100088000 manufactured by Stryker Instruments-kalamazoo.
[40183340]
The failure for oscillating in forward and reverse was duplicated through functional testing. Disassembly and visual inspection by the technician noted the power control board (pcb)/socket was corroded. Corrosion may limit the design properties of the device causing the event. The pcb assembly was replaced.
Patient Sequence No: 1, Text Type: N, H10
[40183341]
It was reported by the user facility that during a procedure the device oscillated in forward and reverse continually. The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences reported.
Patient Sequence No: 1, Text Type: D, B5
[42276810]
Patient Sequence No: 1, Text Type: N, H10
[42276811]
It was reported by the user facility that during a procedure the device oscillated in forward and reverse continually. The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2016-00288 |
| MDR Report Key | 5495917 |
| Report Source | USER FACILITY |
| Date Received | 2016-03-11 |
| Date of Report | 2016-02-15 |
| Date of Event | 2016-02-15 |
| Date Mfgr Received | 2016-02-15 |
| Device Manufacturer Date | 1999-04-20 |
| Date Added to Maude | 2016-03-11 |
| 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 | 2016-03-11 |
| Returned To Mfg | 2016-02-19 |
| 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 | 2016-03-11 |