MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for MICRODRILL SERIES STRAIGHT ATTACHMENT 5100015250 manufactured by Stryker Instruments-kalamazoo.
[134512035]
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program. Reported events: 20? Events were reported for this quarter. ? Product return status: 17 devices were received. 2 devices were not available for evaluation. 1 device investigation type has not yet been determined. ? Evaluation status: confirmed. 10 reported events were confirmed during testing. 4 devices were found to be affected by corrosion. 1 device was found to be affected by shattered bearings. 2 devices were found to be affected by corrosion and debris. 2 devices were found to be affected by lubrication breakdown. 1 device was found to be affected corrosion, debris, and shattered bearings. Not confirmed: 5 reported events were not confirmed during testing; however: 2 devices were found to be affected by corrosion. 1 device was found to be affected by corrosion and debris. 1 device was found to be affected by debris. 1 device was found to be affected by shattered bearings. 1 reported event was not confirmed during testing. In progress: 1 device evaluations are in progress. Additional information: 20? Devices were not labeled for single-use. 20 devices were not reprocessed and reused.
Patient Sequence No: 1, Text Type: N, H10
[134512036]
This report summarizes
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2019-00310 |
| MDR Report Key | 8284966 |
| Date Received | 2019-01-29 |
| Date of Report | 2019-04-29 |
| Date of Event | 2018-12-25 |
| Date Mfgr Received | 2018-12-25 |
| Date Added to Maude | 2019-01-29 |
| 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. ZACH BAKER |
| 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 | 0 |
| Brand Name | MICRODRILL SERIES STRAIGHT ATTACHMENT |
| Generic Name | UNIT, OPERATIVE DENTAL |
| Product Code | EIA |
| Date Received | 2019-01-29 |
| Catalog Number | 5100015250 |
| Lot Number | VMSR |
| Device Availability | N |
| 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 | 2019-01-29 |