MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-07-21 for TPS MICRO DRIVER 5100088000 manufactured by Stryker Instruments-kalamazoo.
[80650276]
The manufacturer intended to submit this report in the q2 2017 asr submission for (b)(4). (b)(4) was placed on hold due to the participation malfunction summary reporting ((b)(4)) on (b)(6) 2017.
Patient Sequence No: 1, Text Type: N, H10
[80650277]
The user facility reported that the device was overheating during testing. There was no medical intervention or adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2017-01393 |
| MDR Report Key | 6731475 |
| Report Source | USER FACILITY |
| Date Received | 2017-07-21 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-03-20 |
| Date Mfgr Received | 2017-03-20 |
| Device Manufacturer Date | 2000-02-10 |
| Date Added to Maude | 2017-07-21 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 |
| Product Code | DZJ |
| Date Received | 2017-07-21 |
| Returned To Mfg | 2017-05-05 |
| Catalog Number | 5100088000 |
| 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 | 2017-07-21 |